Recall Z-1191-2017 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Encore Medical, Lp
LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an
| Date | Feb 11, 2017 (initiated Jan 10, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 13 devices |
| Distribution | US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092331 | DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; Encore Medical L.P., Mar 3, 2010 |