Bone Screw recall
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells…
Why was Bone Screw recalled?
Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .
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?
Item Number Lot Number 00-6250-065-35 62748089 00-6250-065-35 62754329 00-6250-065-35 62793494 00-6250-065-35 62793495 00-6250-065-35 62793501 00-6250-065-35 62793502 00-6250-065-35 62793503 00-6250-065-35 62813612 00-6250-065-35 62813613 00-6250-065-25 62784617 00-6250-065-25 62784618 2 00-6250-065-25 62784619 00-6250-065-25 62784621 00-6250-065-25 62784622 00-6250-065-25 62818701 00-6250-065-25 62818702 00-6250-065-25 62818703 00-6250-065-25 62818707 00-6250-065-25 62818709 00-6250-065-25 62818710 00-6250-065-25 62825611 00-6250-065-25 62836984
- Product
- Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells…
- Recalling firm
- Zimmer Manufacturing B.V.
- Quantity
- 6,377
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada Australia Brazil Chile China Colombia Japan Malaysia Singapore South Korea Taiwan Albania Austria Belgium Bulgaria Canary Islands Czech Republic Denmark Egypt Finland France Germany Greece Hungary Ireland Italy Netherlands Norway Poland Portugal Russia Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey and United Kingdom.
- Recall date
- December 24, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)