PRI Femoral Impactor Block for knee prosthesis surgery — Class II medical device recall Z-1696-2015
Terminated recall by Zimmer, Inc., reported 2015-06-10, distributed nationwide. Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the ass
| Recall number | Z-1696-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-04-30 |
| Classified | 2015-05-29 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-03-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, ES, FR, GB, IL, IN, IR, IS, IT, JP, KR, MY, NO, SA, SE, SG |
| Quantity | 1,689 |
| Reason classes | foreign material, packaging |
| Lot numbers | 56572845, 56573249, 56573282, 56573283, 56573284, 56573285, 56574130, 56574135, 56574136, 56574137, 56574196, 56574197, 56574198, 56574325, 56574326, 56574327, 56574328, 56574329, 56574530, 56574531, 56574532, 56574533, 56574534, 56574535, 56574536, 56574604, 56574605, 56574606, 56574607, 56574608, 56574617, 56574714, 56574774, 56574775, 56575827, 56575828, 56575829, 56575830, 56575831, 56575832 and 13 more |
| Model numbers | 00-5901-032-00, 56572845, 56573249, 56573282, 56573283, 56573284, 56573285, 56574130, 56574135, 56574136, 56574137, 56574196, 56574197, 56574198, 56574325, 56574326, 56574327, 56574328, 56574329, 56574530, 56574531, 56574532, 56574533, 56574534, 56574535 and 29 more |
Product
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Reason for recall
Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1696-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.