Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads.
This recall has been terminated (originally issued December 22, 2009).
- Recall Initiated
- January 14, 2009
- Posted
- December 22, 2009
- Terminated
- July 18, 2012
- Recall Number
- Z-0557-2010
- Quantity
- 786 total stems
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
Distribution
Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.
Lot / Code Info
Catalog Number: J6054-XXXX; All lots codes with an expiry prior to Aug. 2013.
Root Cause
Device Design
Action Taken
Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.
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