Zimmer Biomet Recalls
875 recalls on record · January 20, 2016 to December 30, 2020 · Medical Devices
Recalls by year
16
17
18
19
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 27, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws a
Hazard: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
June 27, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of implants (cannulated screws a
Hazard: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
June 27, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion of implants (cannulated scre
Hazard: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
June 27, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated s
Hazard: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
June 27, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated scre
Hazard: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
June 27, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated scre
Hazard: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
June 27, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated scre
Hazard: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
June 27, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated scre
Hazard: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
June 20, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Hazard: The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
June 20, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 0088
Hazard: One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
May 23, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implanta
Hazard: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
May 23, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantat
Hazard: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
May 23, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for impl
Hazard: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
May 23, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for impla
Hazard: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
May 16, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee
Hazard: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
May 16, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee
Hazard: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
May 16, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee
Hazard: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
May 16, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee
Hazard: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
May 16, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee
Hazard: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
May 16, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee
Hazard: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
May 16, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in
Hazard: The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.
May 9, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-
Hazard: Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
May 9, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesi
Hazard: Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: Th
Hazard: There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Hazard: Potential failure of sterile packaging seal.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
Hazard: Potential failure of sterile packaging seal.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Hazard: Potential failure of sterile packaging seal.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
Hazard: Potential failure of sterile packaging seal.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
Hazard: Potential failure of sterile packaging seal.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Hazard: Potential failure of sterile packaging seal.