Tornier recalls 300+ AEQUALIS FLEX REVIVE Assembly Screw 0mm units (model ARS655101) due to mislabeled parts causing confusion with shorter screws.
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 300+ AEQUALIS FLEX REVIVE Assembly Screw 0mm units (model ARS655101) because the labeling and laser markings were swapped with a shorter screw model. This mix-up could lead to incorrect installation in medical devices, potentially causing improper function or safety issues.
The recall involves a mix-up between two screw models: a standard 0mm length (ARS655101) and a shorter 0mm length (ARS655118). Using the wrong screw could lead to improper device assembly, potentially causing mechanical failure or incorrect function in medical applications.
Users of medical devices that require these screws, particularly those in orthopedic or surgical applications. Patients and healthcare providers using the affected screws are most at risk of incorrect installation.
Check for the model number ARS655101 on the product label or packaging. The serial numbers listed (AZ1822082001 to AZ1822082055) indicate the affected units. The product is sold under the AEQUALIS FLEX REVIVE brand.
Look for the model number ARS655101 and serial numbers from AZ1822082001 to AZ1822082055 on the screw packaging or label.
The labeling and laser markings were swapped between the standard 0mm screw (ARS655101) and the shorter 0mm screw (ARS655118), causing confusion in medical device assembly.
Check for the model number ARS655101 and serial numbers from AZ1822082001 to AZ1822082055 on the screw packaging or label.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected model and serial numbers.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-2019-2023 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-2019-2023 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.
