Reported Jul 5, 2023 · Ongoing
AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
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 0mm Short, Model Number ARS655118
- Lot codes and dates
- GTIN 00846832069408
- Serial Numbers
AZ1322077001AZ1322077002AZ1322077003AZ1322077004AZ1322077005AZ1322077006AZ1322077007AZ1322077008AZ1322077009AZ1322077010AZ1322077011AZ1322077012AZ1322077013AZ1322077014AZ1322077015AZ1322077016AZ1322077017AZ1322077018AZ1322077019AZ1322077020AZ1322077021AZ1322077022AZ1322077023AZ1322077024AZ1322077025AZ1322077026AZ1322077027AZ1322077028AZ1322077029AZ1322077030AZ1322077031AZ1322077032AZ1322077033AZ1322077034AZ1322077035AZ1322077036AZ1322077037AZ1322077038AZ1322077039AZ1322077040AZ1322077041AZ1322077042AZ1322077043AZ1322077044AZ1322077045AZ1322077046AZ1322077047AZ1322077048AZ1322077049AZ1322077050AZ1322077051AZ1322077052AZ1322077053AZ1322077054AZ1322077055
- 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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