CPT 12/14 COCR prosthesis — Class II medical device recall Z-0844-2016
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-0844-2016 |
|---|---|
| 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 | 24,272 |
| Lot numbers | 61744462, 61744471, 61767815, 61770620, 61774067, 61774069, 61774070, 61774071, 61778347, 61778352, 61779345, 61783709, 61783710, 61783712, 61783713, 61783715, 61783716, 61783717, 61787012, 61787026, 61787032, 61787033, 61787039, 61790491, 61790493, 61790501, 61790503, 61794997, 61794998, 61794999, 61795001, 61795002, 61798096, 61798097, 61801163, 61801166, 61801167, 61801169, 61801170, 61801172 and 460 more |
| Model numbers | 00-8114-000-00, 00-8114-000-10, 00-8114-001-00, 00-8114-001-10, 00-8114-002-00, 00-8114-002-10, 00-8114-002-18, 00-8114-002-30, 00-8114-003-00, 00-8114-003-10, 00-8114-003-18, 00-8114-003-30, 00-8114-004-00, 00-8114-004-10, 00-8114-004-20, 00-8114-004-23, 00-8114-004-26, 00-8114-004-30, 00-8114-005-00, 00-8114-005-10, 00-8114-005-30, 00-8114-012-18, 00-8114-013-18 |
Product
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures."
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-0844-2016. 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.