FDA Medical Device Recalls (openFDA)
Tornier, Inc: AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
- Recall number
- Z-2020-2023
- Recalling firm
- Tornier, Inc
- Product
- AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
- 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: AZ1322077001, AZ1322077002, AZ1322077003, AZ1322077004, AZ1322077005, AZ1322077006, AZ1322077007, AZ1322077008, AZ1322077009, AZ1322077010, AZ1322077011, AZ1322077012, AZ1322077013, AZ1322077014, AZ1322077015, AZ1322077016, AZ1322077017, AZ1322077018, AZ1322077019, AZ1322077020, AZ1322077021, AZ1322077022, AZ1322077023, AZ1322077024, AZ1322077025, AZ1322077026, AZ1322077027, AZ1322077028, AZ1322077029, AZ1322077030, AZ1322077031, AZ1322077032, AZ1322077033, AZ1322077034, AZ1322077035, AZ1322077036, AZ1322077037, AZ1322077038, AZ1322077039, AZ1322077040, AZ1322077041, AZ1322077042, AZ1322077043, AZ1322077044, AZ1322077045, AZ1322077046, AZ1322077047, AZ1322077048, AZ1322077049, AZ1322077050, AZ1322077051, AZ1322077052, AZ1322077053, AZ1322077054, AZ1322077055
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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