Recall Z-0834-2018 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
DePuy Orthopaedics, Inc.
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
| Date | Aug 31, 2017 |
| Status | Terminated |
| Reason | The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. |
| Root cause | Nonconforming Material/Component |
| Action | On September 11, 2017 an URGENT MEDICAL DEVICE RECALL notice was issued to customers for specific lots of the DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants. The letter instructs customers to inspect inventory and to remove and return the affected lots to the recalling firm. Questions or concerns can be directed to Kim (Earle) Long, Senior Recall Coordinator, 574-371-4917. |
| Quantity | Quantities co-mingled under initial product |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120174 | DEPUT DELTA XTEND REVERSE SHOULDER Depuy France, Jun 11, 2012 |