Zimmer Biomet Recalls
875 recalls on record · January 20, 2016 to December 30, 2020 · Medical Devices
Recalls by year
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18
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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.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Hazard: Potential failure of sterile packaging seal.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
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, 70 cm length; Item Number: 47-2490-098-01
Hazard: Potential failure of sterile packaging seal.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
Hazard: Potential failure of sterile packaging seal.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
Hazard: Potential failure of sterile packaging seal.
May 2, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2
Hazard: Potential failure of sterile packaging seal.
April 25, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is u
Hazard: There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
April 11, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Hazard: The drill guides were manufactured with the incorrect color anodization.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
Hazard: Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)
Hazard: One lot of humeral stem implants do not include the humeral bushing components.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:
Hazard: Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fr
Hazard: Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LA
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SC
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM S
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM S
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 130DG STRL TROCH NAIL ST 11X180 135
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and un
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X
Hazard: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disabi
Hazard: A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NA
Hazard: The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 80050827
Hazard: The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 S
Hazard: Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
April 4, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5
Hazard: Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
March 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within
Hazard: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
March 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel du
Hazard: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.