device · product 1 of 6
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
- Initiated
- May 04, 2023
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Quantity
- N/A
App-derived interpretation
metal shavings
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
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.
Code information
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
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.