Recall Z-2060-2023— T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

Name: FDA recall Z-2060-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-04

Class II · Ongoing

Class II FDA medical device recall by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD., initiated 2023-05-04. It names one FDA 510(k) clearance: K210498. 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. 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..

Recalling firm: T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Classification: Class II
Status: Ongoing
Initiated: 2023-05-04
Firm location: GAATON, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K210498 — Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.·cleared 2021-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.