CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is i
FDA device recall Z-0843-2016 · posted 2016-02-22 · Terminated
Recall details
- Recalling firm
- Zimmer Biomet, Inc.
- Reason for recall
- LDPE bag containing the implant adheres to the highly polished implant surface.
- Action taken
- Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative. For questions regarding this recall call 800-447-5633.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 289
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC
- Date initiated
- 2016-01-11
- Date posted
- 2016-02-22
- Date terminated
- 2017-05-23
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 (K030265) | Zimmer, Inc. | 2003-03-04 |