ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis — Class II medical device recall Z-0836-2016
Terminated recall by Zimmer Biomet, Inc., reported 2016-03-02, distributed nationwide. LDPE bag containing the implant adheres to the highly polished implant surface.
| Recall number | Z-0836-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-01-11 |
| Classified | 2016-02-22 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-05-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BB, BE, BM, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, ES, FR, GB, GT, HK, HN, HR, IL, IN, IT, JM, JP, KR, MX, MY, NI, NZ, PA, PE, SE, SG, SV, TH, TW, VE |
| Quantity | 32,537 |
| Lot numbers | 11002504, 11002764, 11002766, 11002767, 11002780, 11002782, 11002784, 11003009, 11003028, 11003042, 11003048, 11003345, 11003366, 11003367, 11003370, 11003371, 11003384, 11003398, 11003399, 11003413, 11003414, 11003433, 11003452, 11003488, 11003490, 11003491, 11003584, 11003587, 11003588, 11003589, 11003603, 11003611, 11003635, 11003642, 11003649, 11003658, 11003659, 11003660, 11003661, 11003689 and 460 more |
| Model numbers | 00-5842-011-01, 00-5842-011-02, 00-5842-012-01, 00-5842-012-02, 00-5842-013-01, 00-5842-013-02, 00-5842-014-01, 00-5842-014-02, 00-5842-015-01, 00-5842-015-02, 00-5842-016-01, 00-5842-016-02, 00-5842-017-01, 00-5842-017-02 |
Product
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes 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
LDPE bag containing the implant adheres to the highly polished implant surface.
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-0836-2016. 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.