FDA Device recall Z-0843-2016
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cement…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cement… by Zimmer Biomet, citing LDPE bag containing the implant adheres to the highly polished implant surface.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0843-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
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
LDPE bag containing the implant adheres to the highly polished implant surface.
Identifiers
| code_info | Item numbers: 00-8114-040-00 00-8114-050-00 Lot numbers: 61790499 61878931 61891348 61907682 61993208 61993210…Item numbers: 00-8114-040-00 00-8114-050-00 Lot numbers: 61790499 61878931 61891348 61907682 61993208 61993210 62030932 62038367 62106796 62106797 62148557 62161479 62206538 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0843-2016%22
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