REF S313152 Straight Acetabular Inserter Handle Ringloc recall
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Why was REF S313152 Straight Acetabular Inserter Handle Ringloc 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number 5313152 Lot 153880,153930, 415500, 648010
- Product
- REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
- Recalling firm
- Biomet, Inc.
- Quantity
- 58
- Distribution
- Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
- Recall date
- March 20, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)