RegWardenFDA facility compliance records
Recall

Class II — T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

Recalling firmF & L MEDICAL PRODUCTS LLC
Registered facilityF & L MEDICAL PRODUCTS LLC (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonDrill 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.
ProductBETTA LINK SR 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: 110045151
QuantityN/A
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
Initiated2023-05-04
Classified2023-07-03
Recall numberZ-2063-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. (Z-2063-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92410/

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