Gender PFJ FEMORAL COMP — Class II medical device recall Z-0837-2016
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-0837-2016 |
|---|---|
| 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 | 5,103 |
| Lot numbers | 11003385, 11003487, 11003827, 11003957, 11004055, 11004100, 11004102, 11004106, 11004145, 11004378, 11004444, 11004449, 11004454, 11004464, 11004499, 11005712, 11005779, 11005783, 11006058, 11006623, 11006851, 11006878, 11006925, 11006973, 11008245, 11008259, 11008270, 11008331, 11008381, 61771793, 61771795, 61777453, 61777454, 61777455, 61777456, 61777457, 61782636, 61782637, 61782638, 61782639 and 460 more |
| Model numbers | 00-5926-011-01, 00-5926-011-02, 00-5926-012-01, 00-5926-012-02, 00-5926-013-01, 00-5926-013-02, 00-5926-014-01, 00-5926-014-02, 00-5926-015-01, 00-5926-015-02 |
Product
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
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-0837-2016. 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.