AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Reported: July 5, 2023 Initiated: June 12, 2023 #Z-2019-2023
Product Description
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Reason for Recall
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.
Details
- Recalling Firm
- Tornier, Inc
- Units Affected
- 55 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.
- Location
- Bloomington, MN
Frequently Asked Questions
What product was recalled? ▼
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101. Recalled by Tornier, Inc. Units affected: 55 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2023. Severity: Moderate. Recall number: Z-2019-2023.
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