Zimmer Recalls Trauma Large Screws Due to Packaging Design Failures
Zimmer, Inc. is recalling 972,125 units of sterile-packaged Trauma Large Screws because packaging design verification tests failed, resulting in compromised seal integrity.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is related to packaging integrity and potential loss of sterility, which is a significant but not immediately life-threatening risk.
Plain-English summary
Zimmer, Inc. is recalling 972,125 units of sterile-packaged Trauma Large Screws and related implants and instruments. The affected products include various cannulated bone screws, reconstruction screws, and Z Nail components distributed worldwide. The recall is limited to items with expiration dates prior to July 2024.
The recall was initiated due to packaging design verification test failures. Specifically, multiple test samples from six different package configurations failed simulated distribution and shipping testing. During these tests, the devices either breached the inner or outer package trays, or the seal integrity was lost. This indicates a potential risk to the sterility of the devices.
Healthcare providers and facilities that have received these products should stop using them and contact Zimmer, Inc. for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG CAN
- Manufacturer
- Zimmer, Inc.
- Affected units
- 972,125
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Item Numbers 00114610099
- 00114610500
- 00114610532
- 00114610599
- 00114611000
- 00114611032
- 00114611099
- 00114611500
- 00114611532
- 00114611599
- 00114612000
- 00114612032
- 00114612099
- 00114612500
- 00114612599
- 00114613000
- 00114613099
- 00225210555
- 00225211055
- 00225211555
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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