AEQUALIS FLEX REVIVE recallZ-2020-2023 · Tornier, Inc · initiated Jun 12, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tornier, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2020-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 12, 2023
- Posted by the FDA
- Jun 28, 2023
- Recalling firm
- Tornier, Inc
- Quantity
- 55 units
- Product code
- KWS
- FDA submissions
- K191318
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.
Product description
AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AEQUALIS™ FLEX REVIVE™ ARS655101Tornier, Inc. · shoulder prosthesis, reverse configuration2 recalls2 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K191318 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Tornier HRS ARS980904Tornier, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- Tornier HRS ARS741809Tornier, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier HRS ARS980902Tornier, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- Tornier HRS ARS741807Tornier, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier HRS ARS741813Tornier, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 92520).
- Z-2019-2023 · Open, ClassifiedAEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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