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Terminated

Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.

FDA Recall Z-2733-2020 · Posted None

Recalling FirmArthrex, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2020-06-24
Date Terminated2021-02-16
Product Quantity28 units

Reason for Recall

Screws provided in packaging are 5mm shorter than intended

Firm Action

Arthrex initiated recall on 06/24/2020. The notification states the following: 1 . Immediately discontinue use, sale, and distribution of the product. 2. Direct Customers (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or [email protected]. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 3. Arthrex Subsidiaries (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or [email protected]. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 4. Arthrex Subsidiaries (APAC): a. Please contact Arthrex Product Surveillance at 866-267-9138 or [email protected]. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 5. If you have any questions about this product recall, please contact Arthrex Product Surveillance at 866-267-9138 or [email protected].

Root Cause

Process control

Distribution Pattern

International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands

Official Source

View FDA Recall →

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

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