Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplast
FDA device recall Z-1042-2015 · posted 2015-02-03 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip
- Action taken
- On 11/25/2014, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected distributors, hospital Risk Managers and Surgeons with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers, Surgeons, and distributors with affected inventory were also notified via courier. 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. For questions, call the customer call center at 1-800-348-2759.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1,091
- Distribution
- Worldwide distribution: US nationwide, including Puerto Rico, South Korea, Singapore, Dominican Republic, Canada, Japan, and Germany.
- Date initiated
- 2014-11-25
- Date posted
- 2015-02-03
- Date terminated
- 2015-12-01
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER PERSONA KNEE SYSTEM (K113369) | Zimmer, Inc. | 2012-03-27 |