EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee repl
FDA device recall Z-0970-2015 · posted 2015-01-14 · Terminated
Recall details
- Recalling firm
- Stelkast Co
- Reason for recall
- Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
- Action taken
- On December 1, 2014, phone calls were made to all direct accounts to notify them of the recall and to request immediate recovery and return of the SC3425 EXp PS Tibial Tray Inserts and SC3453 EXp CR-HF Inserts from their inventory.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 553
- Distribution
- TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.
- Date initiated
- 2014-12-01
- Date posted
- 2015-01-14
- Date terminated
- 2015-05-06
- Location
- Mcmurray, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM (K122883) | Stelkast Company | 2013-08-05 |