BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligamen
Summary
The FDA issued a Class II for BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixat by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.. 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 dril.
Details
Source
Device Recall
External ID
Z-2061-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
Product Description
BETTA LINK LG 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: 110045160
Lot/Code Info: UDI-DI: 10818674025772 Lot Numbers: 21E28, 21R15, 21R16, 21R32, 21R35, 22C19, 22E29, 22F10, 22F35, 22J07, 22J08, 22J09, 22J18, 22J19, 22J27, 22J28, 22J33, 22K23, 22K24, 22K32, 22K33, 22K38, 22M03, 22M04, 22M24, 22P03, 22P09, 22P10, 22P11, 22P13, 22P14, 22P16
Quantity Affected: N/A
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-04
Company
GAATON, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 287 device recalls issued in the same week, part of 403 device-related FDA actions this month.
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. has 9 FDA actions in our database, including 6 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. have FDA actions?
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. has 9 FDA actions in our database, including 6 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2061-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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