Orthopedic assembly screws with incorrect model number labeling and markings
AEQUALIS FLEX REVIVE assembly screws were mislabeled during manufacturing, with some units marked as 0mm Standard actually being 0mm Short and vice versa. Surgeons must verify model numbers before use.
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 recall involving mislabeling of orthopedic implants where wrong screw size could be implanted during surgery. No reported injuries to date, but the risk-of-harm from implant size confusion justifies High severity under the rubric criterion for risk-of-harm products without yet-reported injuries.
Plain-English summary
Tornier, Inc is recalling AEQUALIS FLEX REVIVE Assembly Screw 0mm Short (Model ARS655118) due to a labeling error that resulted in incorrect product identification. Some affected units were marked as AEQUALIS FLEX REVIVE Assembly Screw 0mm Standard (Model ARS655101) when they were actually 0mm Short, and some 0mm Standard units were marked as 0mm Short.
This labeling mix-up creates a risk that surgeons may implant the wrong screw size during orthopedic procedures. Using an incorrectly sized implant could result in surgical complications or the need for corrective revision surgery.
The recall affects 55 units with serial numbers AZ1322077001 through AZ1322077055. These screws were distributed worldwide to the United States, Australia, Canada, Netherlands, Spain, and United Kingdom.
Healthcare facilities and surgeons who received these implants should immediately verify the serial numbers and model numbers of their inventory. Any units with the affected serial numbers should be quarantined and not used for surgical implantation until the correct identification is confirmed with Tornier, Inc.
The recalled product
- Product
- AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
- Manufacturer
- Tornier, Inc
- Hazard
- mis-labeling
- implant-confusion
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: AZ1322077001
- AZ1322077002
- AZ1322077003
- AZ1322077004
- AZ1322077005
- AZ1322077006
- AZ1322077007
- AZ1322077008
- AZ1322077009
- AZ1322077010
- AZ1322077011
- AZ1322077012
- AZ1322077013
- AZ1322077014
- AZ1322077015
- AZ1322077016
- AZ1322077017
- AZ1322077018
- AZ1322077019
Distribution
Distributed nationwide across the United States.
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