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Open, Classified

Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045157

FDA Recall Z-2065-2023 · Posted 2023-07-03

Recalling FirmT.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Recall StatusOpen, Classified
Product CodeLXH
Date Initiated2023-05-04

Reason for Recall

Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.

Firm Action

Zimmer Biomet issued Alert - Field Safety Notice with TAG Letter to consignees by email. on 5/4/23. Letter states reason for recall, health risk and action to take: 1. Immediately discontinue use, sale and distribution of the above products. 2. Please contact Zimmer Biomet at [email protected] for questions and clarifications. 3. Our product surveillance specialists are available to answer questions regarding credit for affected devices in your possession. 4. The attached form must be used and sent back immediately. " Complete the Customer Response Form and return it to [email protected] " Immediately quarantine and return the impacted products to Zimmer Biomet at: Zimmer Biomet Product Service Department ATTN: RECALLS 1777 West Center Street Warsaw, IN 46580 You may direct any questions regarding the recall to [email protected].

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.

Official Source

View FDA Recall →

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

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