Reported Jul 5, 2023 · Ongoing
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Tornier, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109
Is this the product you have?
AEQUALIS FLEX REVIVE Assembly Screw 0mmModel Number ARS655101
- Lot codes and dates
- GTIN 00846832069408
- Serial Numbers
AZ1822082001AZ1822082002AZ1822082003AZ1822082004AZ1822082005AZ1822082006AZ1822082007AZ1822082008AZ1822082009AZ1822082010AZ1822082011AZ1822082012AZ1822082013AZ1822082014AZ1822082015AZ1822082016AZ1822082017AZ1822082018AZ1822082019AZ1822082020AZ1822082021AZ1822082022AZ1822082023AZ1822082024AZ1822082025AZ1822082026AZ1822082027AZ1822082028AZ1822082029AZ1822082030AZ1822082031AZ1822082032AZ1822082033AZ1822082034AZ1822082035AZ1822082036AZ1822082037AZ1822082038AZ1822082039AZ1822082040AZ1822082041AZ1822082042AZ1822082043AZ1822082044AZ1822082045AZ1822082046AZ1822082047AZ1822082048AZ1822082049AZ1822082050AZ1822082051AZ1822082052AZ1822082053AZ1822082054AZ1822082055
- Amount recalled
- 55 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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