FDA Medical Device Recalls (openFDA)
Tornier, Inc: AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
- Recall number
- Z-2019-2023
- Recalling firm
- Tornier, Inc
- Product
- AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
- Status
- Open, Classified
- Initiated
- 2023-06-12
- Posted
- 2023-06-28
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- GTIN 00846832069408, Serial Numbers: AZ1822082001, AZ1822082002, AZ1822082003, AZ1822082004, AZ1822082005, AZ1822082006, AZ1822082007, AZ1822082008, AZ1822082009, AZ1822082010, AZ1822082011, AZ1822082012, AZ1822082013, AZ1822082014, AZ1822082015, AZ1822082016, AZ1822082017, AZ1822082018, AZ1822082019, AZ1822082020, AZ1822082021, AZ1822082022, AZ1822082023, AZ1822082024, AZ1822082025, AZ1822082026, AZ1822082027, AZ1822082028, AZ1822082029, AZ1822082030, AZ1822082031, AZ1822082032, AZ1822082033, AZ1822082034, AZ1822082035, AZ1822082036, AZ1822082037, AZ1822082038, AZ1822082039, AZ1822082040, AZ1822082041, AZ1822082042, AZ1822082043, AZ1822082044, AZ1822082045, AZ1822082046, AZ1822082047, AZ1822082048, AZ1822082049, AZ1822082050, AZ1822082051, AZ1822082052, AZ1822082053, AZ1822082054, AZ1822082055
- 510(k) numbers
- ["K191318"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 3000718467
- Firm city
- Bloomington
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28