Linvatec Corp. Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable Driver***STERILE***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable Driver***STERILE***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''.
Brand
Linvatec Corp.
Lot Codes / Batch Numbers
Lot # ''s BBB34096, BBB35001, BBB38590, BBB47862, BBB56209, BBB59492, BBB61957, BBB63207, BBB66991, BBB69760, BBB70775.
Products Sold
Lot # ''s BBB34096, BBB35001, BBB38590, BBB47862, BBB56209, BBB59492, BBB61957, BBB63207, BBB66991, BBB69760, BBB70775.
Linvatec Corp. is recalling Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C due to Linvatec has determined that there is a possibility that the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Pa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Linvatec has determined that there is a possibility that the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices.
Recommended Action
Per FDA guidance
Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026