FDA Device recall Z-0844-2016
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemen…
- 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 cemen… 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-0844-2016 |
| 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: 00-8114-000-00 00-8114-000-10 00-8114-001-00 00-8114-001-10 00-8114-002-00 00-8114-002-10 00-8114-…Item 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 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 61801173 61801175 61803852 61803853 61803854 61803855 61803856 61803857 61806780 61806781 61806783 61806784 61806785 61806786 61806795 61809116 61809117 61809118 61809119 61809120 618 |
|---|
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-0844-2016%22
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