Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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Implants & Prosthetics
🏥 Medical Devices • 4,540 recalls
Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet
Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet
Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet
Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet
Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet
Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet
Class I - Dangerous
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
nail not properly engaging with the targeting jig due to certain undersized specification
Class I - Dangerous
Durability characteristics of reusable instruments were not established
Class I - Dangerous
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.
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
EBI Patient Care
Class I - Dangerous
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
EBI Patient Care
Class I - Dangerous
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
Navitrack System - OS Knee Universal, Stereotaxic instrument
Orthosoft, Inc.
Class I - Dangerous
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .
Class I - Dangerous
ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Class I - Dangerous
Missing Dome Pack accessory.