FDAFDA · Food and drugs·Recall number Z-0716-2014
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Published January 22, 2014 · Recall initiated: December 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
- Lot
- Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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