FDAFDA · Food and drugs·Recall number Z-0925-2013
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Published March 20, 2013 · Recall initiated: February 5, 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
The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
- Lot
- Catalog Number 5313152 Lot 153880,153930, 415500, 648010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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