FDAFDA · Food and drugs·Recall number Z-0164-2013
"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
Published November 7, 2012 · Recall initiated: April 9, 2012
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
ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Distributor
- Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
- Lot
- Lot # 330889 and Catalog: PFT-00M - No Expiration date
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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