Orthopedic Assembly Screws Recalled Due to Labeling and Size Swap Error
Tornier recalled 55 AEQUALIS FLEX REVIVE Assembly Screws (Model ARS655101) due to a labeling swap where Standard-length units were marked Short, and vice versa. This could result in implantation of the wrong screw size during orthopedic surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II labeling and identification error on surgical implants (orthopedic screws) that could result in implantation of incorrect screw length. No injuries or illnesses reported. Classified as risk-of-harm product without yet-reported injury per the rubric, scoring at 3.
Plain-English summary
Tornier, Inc. recalled 55 units of AEQUALIS FLEX REVIVE Assembly Screw 0mm (Model Number ARS655101) distributed worldwide, including the United States, Australia, Canada, Netherlands, Spain, and the United Kingdom.
A labeling and laser marking error resulted in a comingle/swap of product identification: some units labeled as AEQUALIS FLEX REVIVE Assembly Screw 0mm Standard (ARS655101) were actually AEQUALIS FLEX REVIVE Assembly Screw 0mm Short (ARS655118), and vice versa. This labeling discrepancy could result in the wrong screw size being used during orthopedic surgical implantation.
Healthcare providers should verify the actual screw size against the product labeling before use. Contact Tornier, Inc. for instructions on product identification, replacement, or return of affected units. The recalled products are identified by GTIN 00846832069408 and serial numbers AZ1822082001 through AZ1822082055.
The recalled product
- Product
- AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
- Manufacturer
- Tornier, Inc
- Hazard
- labeling-error
- product-swap
- size-mismatch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00846832069408
- Serial Numbers: AZ1822082001
- AZ1822082002
- AZ1822082003
- AZ1822082004
- AZ1822082005
- AZ1822082006
- AZ1822082007
- AZ1822082008
- AZ1822082009
- AZ1822082010
- AZ1822082011
- AZ1822082012
- AZ1822082013
- AZ1822082014
- AZ1822082015
- AZ1822082016
- AZ1822082017
- AZ1822082018
- AZ1822082019
Distribution
Distributed nationwide across the United States.
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