Recall Z-2020-2023 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Tornier, Inc
AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
| Date | Jun 28, 2023 (initiated Jun 12, 2023) |
| Status | Open, Classified |
| Reason | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. |
| Root cause | Under Investigation by firm |
| Action | Tornier issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees beginning on 06/12/2023 by email and letter. The notice explained the problem, the risk associated with its use, and requested that the affected devices be isolated/quarantined pending return. Distributors were directed to notify their customers. |
| Quantity | 55 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191318 | AEQUALIS FLEX REVIVE Shoulder System Tornier, Inc., Jun 14, 2019 |