Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 4723...
FDA Device Recall #Z-0317-2020 — Class II — October 10, 2019
Recall Summary
| Recall Number | Z-0317-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 10, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Biomet, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 5,459,583 total devices |
Product Description
Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 47235800515 47235800519 47235800603 47235800605 47235800607 47235800609 47235800611 47235800615 47235800619 47235800705 47235800711 47235800715 47235800803 47235800805 47235800807 47235800811 47235800815 47235800911 47235800913 47235800915 47235801209 47235801211 47235801213 47235801215 47235802305 47235802307 47235802311 47235802315 47235802405 47235802407 47235802409 47235802411 47235802415 47235810707 47235810711 47235810715 47235810805 47235810807 47235810811 47235810815
Reason for Recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Distribution Pattern
Distributed nationwide.
Lot / Code Information
All product manufactured prior to January 2014.
Other Recalls from Zimmer Biomet, Inc.
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|---|---|---|---|
| Z-0696-2021 | Class II | Spinal Rod Cutter, Item number 00392500200. The... | Nov 20, 2020 |
| Z-0570-2021 | Class II | Polaris 5.5 Spinal System and Polaris 5.5/Cyphe... | Nov 17, 2020 |
| Z-0372-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslink... | Sep 24, 2020 |
| Z-0345-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslink... | Sep 24, 2020 |
| Z-0347-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslink... | Sep 24, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.