Z-1548-05

Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY...

Name: Z-1548-05 Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY...
Creator: Linvatec Corp.
Published: 2005-02-22
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2005-02-22 / Terminated / root cause: packaging

FDA source

Linvatec Corp. began a recall of Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver... on 2005-02-22. The reason FDA records is "Linvatec has determined there is a possibility 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1548-05
Status: Terminated
Initiated: 2005-02-22
Posted: 2005-09-21
Terminated: 2012-07-07
Recalling firm: Linvatec Corporation
Product: Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver, Preloaded with One #2 Herculine Suture***STERILE ***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Linvatec has determined there is a possibility 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.
Root cause tag: packaging
FDA root cause: Other
Action: Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
Quantity in commerce: 289 Units
Distribution: Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).
Product codes and lots: Lot #''s BBB65719, BBB67474, BBB68490

Product code JDI

K042778Class IIBioanchor with Disposable Driver, Preloaded with One #2 Herculine SutureLinvatec Corp. / cleared 2004-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)