Home / Brands / Stryker Howmedica Osteonics
Stryker Howmedica Osteonics Recalls
87 recalls on record · June 27, 2012 to May 31, 2017 · Medical Devices
Recalls by year
12
13
14
15
16
17
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 31, 2017Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Pro
Hazard: Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.
January 18, 2017Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrume
Hazard: Reunion TSA Peg Alignment Sound broke during surgery.
December 28, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-
Hazard: A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.
November 16, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed
Hazard: Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
October 19, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp.
Hazard: Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.
September 21, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer
Hazard: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
September 21, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fi
Hazard: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
September 21, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpi
Hazard: Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
August 17, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter
Hazard: Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
August 17, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement
Hazard: It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
August 17, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S P
Hazard: Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.
August 3, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog N
Hazard: Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
April 27, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls VariAx Compression Plating System
Hazard: Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fra
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone seg
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segme
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone se
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segm
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segme
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone seg
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segme
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segment
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segm
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone se
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragm
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segment
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragmen
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
March 2, 2016Medical DevicesFDA
Stryker Howmedica Osteonics Corp. recalls Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone
Hazard: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.