Recall Z-0179-2016 ยท HWA Impactor
Encore Medical, Lp
Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both
| Date | Sep 14, 2015 |
| Status | Terminated |
| Reason | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. |
| Root cause | Device Design |
| Action | DJO Global sent an Urgent Field Safety Notice dated September 15, 2015, to all affected consignees. The notice identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed become familiar with the new techniques and notify all of their applicable users of the RSP Monoblock and Turon stems of these revised methods. When each user has been notified of these new techniques, they should complete the form that was provided with the notification indicating that they have been informed of these changes and understand the new methods. Consignees were |
| Quantity | 277 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.