Z-2060-2023Class II

BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the...

Name: Z-2060-2023 BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the...
Creator: T.a.g. Medical Products Corporation, Ltd.
Published: 2023-05-04
License: https://open.fda.gov/license/

T.A.G. Medical Products Corporation Ltd / initiated 2023-05-04 / Open, Classified / root cause: design

FDA source

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. began a recall of 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... on 2023-05-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2060-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-04
Posted: 2023-07-03
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
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
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.
Root cause tag: design
FDA 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 [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].
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2060-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2060-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2061-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2062-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2063-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2064-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2065-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03

Product code MBI

K210498Class IIBetta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd. / cleared 2021-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)