3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intende
FDA device recall Z-2302-2012 · posted 2012-08-30 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
- Action taken
- DJO Global sent an Urgent Field Safety Notice dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Notice to all those who need to be aware within their organization or to any organization where the potentially affected product has been transferred. Customers were instructed to contact the firm to place a replacement order and receive an RMA number. For questions customers were asked to call 512-834-6255. For questions regarding this recall call 512-832-9500.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- OIY
- Quantity affected
- 7 units
- Distribution
- Worldwide Distribution including Venezuela.
- Date initiated
- 2012-08-09
- Date posted
- 2012-08-30
- Date terminated
- 2013-01-25
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 (K091956) | Encore Medical L.P. | 2010-09-28 |