AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catal
FDA device recall Z-0626-2016 · posted 2016-01-09 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- The trial shell mating feature on the broach is undersized.
- Action taken
- The recalling firm notified customers of the recall via letter on 12/8/15.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- PHX
- Quantity affected
- 23 units
- Distribution
- Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
- Date initiated
- 2015-12-08
- Date posted
- 2016-01-09
- Date terminated
- 2016-03-01
- 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 |