FDA recall Z-2065-2023

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. · Class II · device

Product

Betta Link LG 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: 110045157

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2023-05-04
Report date: 2023-07-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: GAATON, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2065-2023