Recall Z-2739-2011 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Encore Medical, Lp
Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The p
| Date | Jul 6, 2011 (initiated Apr 18, 2011) |
| Status | Terminated |
| Reason | The device has the potential to not appropriately mate with the humeral stem. |
| Root cause | Nonconforming Material/Component |
| Action | DJO Surgical sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructed customers to quarantine affected products and to contact Customer Service to obtain replacement products and a RMA. Questions are directed to the Director of Commercial Logistics at 512-834-6330. |
| Quantity | 81 units |
| Distribution | Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, LA, MA, MD, ME, NM, NY, OK, PA, SC, TN, TX, UT, and WA and the countries of Germany, Italy, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051075 | ENCORE REVERSE SHOULDER PROSTHESIS Encore Medical L.P., May 27, 2005 |