3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758
FDA device recall Z-1539-2008 · posted 2008-08-20 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.
- Action taken
- Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 6 units.
- Distribution
- Distribution --- country of Germany.
- Date initiated
- 2008-02-20
- Date posted
- 2008-08-20
- Date terminated
- 2008-09-02
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3D KNEE (K020114) | Encore Orthopedics, Inc. | 2002-07-12 |