FDA Medical Device Recalls (openFDA)
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.: BETTA LINK SR KNOTLESS IMPLANT KIT-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:110045154
- Recall number
- Z-2060-2023
- Recalling firm
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Product
- BETTA LINK SR KNOTLESS IMPLANT KIT-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:110045154
- Status
- Open, Classified
- Initiated
- 2023-05-04
- Posted
- 2023-07-03
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- 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 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.
- Quantity
- not on file
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
- Lot, serial or model codes
- UDI-DI: 0818674025765 Lot Numbers: 21R01, 21R02, 21R03, 22C02, 22C03, 22C06, 22C08, 22E01, 22E02, 22F01, 22F02, 22F03, 22J01, 22J02, 22J03, 22K01, 22K02, 22K03, 22K04, 22K05, 22K07, 22K08, 22K09, 22K10, 22K11, 22M01, 22M02, 22M03, 22M04, 22N01, 22P01, 22P02, 22P03, 22P04, 22P05, 22R01
- 510(k) numbers
- ["K210498"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 1000272060
- Firm city
- Gatton GAATON
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28