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Open, Classified

AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

FDA Recall Z-2019-2023 · Posted 2023-06-28

Recalling FirmTornier, Inc
Recall StatusOpen, Classified
Product CodeKWS
Date Initiated2023-06-12
Product Quantity55 units

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.

Firm Action

Tornier issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees beginning on 06/12/2023 by email and letter. The notice explained the problem, the risk associated with its use, and requested that the affected devices be isolated/quarantined pending return. Distributors were directed to notify their customers.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc. · 2019-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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