FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ F...
FDA Device Recall #Z-1055-2018 — Class II — November 29, 2017
Recall Summary
| Recall Number | Z-1055-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 29, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Biomet, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 13,227 in total |
Product Description
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Reason for Recall
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
Lot / Code Information
00-5790-020-00 00-5790-021-00 00-5790-022-00 00-5790-023-00 00-5790-024-00 00-5790-025-00 00-5790-026-00 00-5790-027-00 00-5790-028-00 00-5790-029-00 00-5790-030-00 00-5790-031-00 00-5790-020-00 61855504 00-5790-020-00 11004267 00-5790-020-00 61933229 00-5790-020-00 61915949 00-5790-020-00 11005144 00-5790-020-00 61949771 00-5790-020-00 62062057 00-5790-020-00 77001776 00-5790-022-00 61788933 00-5790-022-00 61810168 00-5790-022-00 61831670 00-5790-022-00 61894364 00-5790-022-00 11004689 00-5790-022-00 61910487 00-5790-022-00 61932359 00-5790-022-00 11004850 00-5790-022-00 61939861 00-5790-022-00 61958404 00-5790-022-00 61993535 00-5790-022-00 61987879 00-5790-022-00 62041075 00-5790-022-00 62074833 00-5790-022-00 11006797 00-5790-022-00 77001778 00-5790-024-00 61788934 00-5790-024-00 61805631 00-5790-024-00 61822278 00-5790-024-00 61928510 00-5790-024-00 61952565 00-5790-024-00 62025572 00-5790-024-00 62054459 00-5790-024-00 62068114 00-5790-024-00 62080645 00-5790-024-00 62105235 00-5790-024-00 77001780 00-5790-024-00 62110658 00-5790-026-00 61777601 00-5790-026-00 61815430 00-5790-026-00 61824552 00-5790-026-00 61952567 00-5790-026-00 62005615 00-5790-026-00 11006199 00-5790-026-00 62062058 00-5790-026-00 62086067 00-5790-026-00 77001782 00-5790-028-00 61831671 00-5790-028-00 62062059 00-5790-028-00 11006735 00-5790-028-00 77001784 00-5790-030-00 61881087 00-5790-030-00 61968455 00-5790-030-00 77001786 00-5790-021-00 61933230 00-5790-021-00 11005163 00-5790-021-00 11005243 00-5790-021-00 62013359 00-5790-021-00 11006254 00-5790-021-00 62086803 00-5790-021-00 77001777 00-5790-023-00 11003416 00-5790-023-00 61795864 00-5790-023-00 11003680 00-5790-023-00 61810169 00-5790-023-00 11003843 00-5790-023-00 61889207 00-5790-023-00 61904081 00-5790-023-00 61933231 00-5790-023-00 61928509 00-5790-023-00 61949247 00-5790-023-00 61993546 00-5790-023-00 62020300 00-5790-023-00 62056497 00-5790-023-00 62074834 00-5790-023-00 77001779 00-5790-025-00 61777599 00-5790-025-00 61795865 00-5790-025-00 61822279 00-5790-025-00 61899451 00-5790-025-00 61928511 00-5790-025-00 61936678 00-5790-025-00 61952566 00-5790-025-00 11005169 00-5790-025-00 62000808 00-5790-025-00 62020301 00-5790-025-00 62056498 00-5790-025-00 62074835 00-5790-025-00 62080646 00-5790-025-00 11006839 00-5790-025-00 62104129 00-5790-025-00 77001781 00-5790-027-00 61782626 00-5790-027-00 61824553 00-5790-027-00 61921258 00-5790-027-00 61952568 00-5790-027-00 62045723 00-5790-027-00 62068115 00-5790-027-00 62092386 00-5790-027-00 77001783 00-5790-029-00 61805632 00-5790-029-00 62005616 00-5790-029-00 77001785 00-5790-031-00 62002487 00-5790-031-00 77001787
Other Recalls from Zimmer Biomet, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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.