AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orth
FDA device recall Z-1241-2018 · posted 2018-03-05 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
- Action taken
- The firm disseminated their field safety notices on 01/30/2018 by email. The letter identified the affected product, problem and actions to be taken. The notices requested the trails be returned for replacement.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- PHX
- Quantity affected
- 387 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2018-01-30
- Date posted
- 2018-03-05
- Date terminated
- 2023-05-30
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENCORE HUMERAL SHOULDER STEM (K141990) | Encore Medical L.P. | 2014-11-07 |