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Recall Observatory FDA recall evidence

Device product

REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument

Z-0925-2013

February 05, 2013

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 64354
Status
Terminated
Classification
Class II
Quantity
58
Official record key
device-enforcement:Z-0925-2013

Official wording

Reason: 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.

Code information: Catalog Number 5313152 Lot 153880,153930, 415500, 648010

Distribution pattern: Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.