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BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in… recallZ-2063-2023 · T.A.G. Medical Products Corporation, Ltd. · initiated May 4, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from T.A.G. Medical Products Corporation, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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].

Recall details

Recall number
Z-2063-2023
Status
Open, Classified
Initiated by the company
May 4, 2023
Posted by the FDA
Jul 3, 2023
Recalling firm
T.A.G. Medical Products Corporation, Ltd.
Product code
LXH
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.

Product description

BETTA LINK SR 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: 110045151

Code information (models, lots, serial numbers)

UDI-DI: 10818674025826 Lot Numbers: 22A01, 22C01,22C02

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 92410).

Sources and updates

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