Tornier recalls 55 specific AEQUALIS FLEX REVIVE Assembly Screws (model ARS655118) due to labeling error with standard screws. This mix-up could cause incorrect assembly in medical devices.
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.
Tornier is recalling 55 specific AEQUALIS FLEX REVIVE Assembly Screws (model ARS655118) because they were mislabeled as the standard length screw instead of the short length. This mix-up could lead to incorrect assembly in medical devices, potentially causing improper function or safety issues.
The screws were mislabeled as the standard length (ARS655101) when they are actually short (ARS655118). This mix-up could lead to incorrect assembly in medical devices, potentially causing improper function or safety issues if used in applications requiring precise fit.
Users of medical devices that require these screws, particularly those with specific surgical applications. Patients and medical professionals using the affected screws are most at risk.
Check for model number ARS655118 on the screw packaging or label. The screws have serial numbers starting with AZ1322077001 to AZ1322077055. They were sold with the GTIN 00846832069408.
Look for model number ARS655118 and serial numbers starting with AZ1322077001 to AZ1322077055 on the screw packaging or label.
The screws were mislabeled as the standard length (ARS655101) when they are actually short (ARS655118), which could lead to incorrect assembly in medical devices.
Check for model number ARS655118 and serial numbers starting with AZ1322077001 to AZ1322077055 on the screw packaging or label.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected screws.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-2020-2023 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-2020-2023 from Tornier. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
