Recall Z-3021-2020 ยท PHX Shoulder Prosthesis, Reverse Configuration
Encore Medical, LP
RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
| Date | Aug 7, 2020 |
| Status | Open, Classified |
| Reason | Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery. |
| Root cause | Other |
| Action | Letters were sent to the firm's Field/Sales Agents by email beginning on August 7, 2020. The letters included instructions to take the following actions by August 21, 2020: 1. Pass the notice on to all those within your organization or to any organization where the potentially affected product has been transferred, 2.Contact Customer Service at 1-800-456- 8696 to place a replacement order and receive a Return Materials Authorization (RMA) number, and to be provided with a shipping label to return the affected product. 3. Return all affected devices using the RMA number, and 4. Report any adver |
| Quantity | 15 units |
| Distribution | Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141006 | RSP HUMERAL SOCKET INSERT Djo Global, Jun 5, 2014 |