NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty wh
FDA device recall Z-1575-2015 · posted 2015-05-01 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery
- Action taken
- On 4/2/2015, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. All distributors were notified via electronic mail, 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. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 20 units
- Distribution
- Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.
- Date initiated
- 2015-04-02
- Date posted
- 2015-05-01
- Date terminated
- 2015-09-23
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES (K960279) | Zimmer, Inc. | 1996-04-26 |