AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
FDA device recall Z-2020-2023 · posted 2023-06-28 · Open, Classified
Recall details
- Recalling firm
- Tornier, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KWS
- Quantity affected
- 55 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.
- Date initiated
- 2023-06-12
- Date posted
- 2023-06-28
- Location
- Bloomington, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEQUALIS FLEX REVIVE Shoulder System (K191318) | Tornier, Inc. | 2019-06-14 |