REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Reported: March 20, 2013 Initiated: February 5, 2013 #Z-0925-2013
Product Description
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Reason for Recall
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 58
- Distribution
- Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument. Recalled by Biomet, Inc.. Units affected: 58.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2013. Severity: Moderate. Recall number: Z-0925-2013.
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