MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
FDA device recall Z-2242-2016 · posted 2016-07-19 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.
- Action taken
- The recalling firm notified affected consignees via letter on 6/21/16. The consignees were instructed to return the affected devices.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 14 (7 sets)
- Distribution
- CO, ID, TX
- Date initiated
- 2016-06-21
- Date posted
- 2016-07-19
- Date terminated
- 2017-01-10
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENCORE LINEAR POROUS COATED HIP (K974294) | Encore Orthopedics, Inc. | 1998-01-12 |