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Terminated

Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

FDA Recall Z-1380-2021 · Posted None

Recalling FirmArthrex, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2021-03-11
Date Terminated2024-10-29
Product Quantity32 units

Reason for Recall

It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

Firm Action

A Recall notification letter titled, "URGENT: RECALL NOTIFCIATION" was sent to consignees on 03/11/2021 via email. The email sent to the consignees requested that the parts be returned. Additionally, the firm is currently awaiting all distributed units to be returned. The recalling firm requested that consignees immediately discontinue use, sale, and distribution of the product. Instructions were provided for Arthrex Agencies (North America), Arthrex Subsidiaries (LATAM and APAC), direct customers (EMEA), and Arthrex Subsidiaries (EMEA) as follows: Arthrex Agencies (North America): Please contact Arthrex Product Surveillance at 866-267-9138 or [email protected]. The consignee is not required to notify patients of the product recall. Arthrex Subsidiaries (LATAM and APAC): Please contact Arthrex Product Surveillance at 866-267-9138 or [email protected]. The consignee is not required to notify patients of the product recall. Direct customers (EMEA): Please contact Arthrex Product Surveillance at +49 89 90 90 05 5240 or [email protected]. The consignee is not required to notify patients of the product recall. Arthrex Subsidiaries (EMEA): Please contact Arthrex Product Surveillance at +49 89 90 90 05 5240 or [email protected]. The consignee is not required to notify patients of the product recall.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032187ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEMArthrex, Inc. · 2003-09-22

Official Source

View FDA Recall →

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

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