LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a
FDA device recall Z-1191-2017 · posted 2017-02-11 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.
- Action taken
- DJO Global sent an Urgent Field Safety Notice letter dated January 10, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the Acknowledgement and receipt Form. Customers were instructed to contact Customer Service at 1-800-456-8696 to explore options for a replacement order.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWA
- Quantity affected
- 13 devices
- Distribution
- US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
- Date initiated
- 2017-01-10
- Date posted
- 2017-02-11
- Date terminated
- 2017-03-31
- 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 |
|---|---|---|
| DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; (K092331) | Encore Medical L.P. | 2010-03-03 |