Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural lig

FDA device recall Z-2065-2023 · posted 2023-07-03 · Open, Classified

Recall details

Recalling firm

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

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.

Action taken

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 CorporateQuality.PostMarket@zimmerbiomet.com 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 CorporateQuality.PostMarket@zimmerbiomet.com " 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 CrporateQuality.PostMarket@zimmerbiomet.com.

Root cause

Device Design

Status

Open, Classified

Product code

LXH

Distribution

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

Date initiated

2023-05-04

Date posted

2023-07-03

Location

Gatton GAATON, Israel