Zimmer Recalls Trauma Tubes and Plates Due to Packaging Failures
Zimmer, Inc. is recalling specific trauma tubes and plates 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. The hazard is a packaging integrity failure (loss of sterility) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling sterile-packaged trauma tubes and plates and instruments. The recall covers 972,125 units distributed worldwide. The affected products include various configurations of TUBE & SCP PLT, VERSA-FX II SC TUBE PLT, VERSA-FX KEYLESS, VERSA-FX II STD TUBE, and VERSA-FX II KEYLESS TB models.
The recall was initiated due to packaging design verification test failures. Multiple test samples from six different package configurations failed simulated distribution and shipping testing. During these tests, the devices either breached inner or outer package trays or lost seal integrity. The source text does not report any illnesses, injuries, or deaths associated with these devices.
Consumers and healthcare providers should check their inventory for the specific item numbers listed in the recall notice. Affected units are those with expiration dates prior to July 2024. Users should stop using these specific sterile-packaged implants and instruments and contact Zimmer, Inc. for further instructions or replacement.
The recalled product
- Product
- Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SC
- 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: 00118109006
- 00118109008
- 00118109010
- 00118109506
- 00118109508
- 00118109510
- 00118113008
- 00118113010
- 00118113012
- 00118113014
- 00118113508
- 00118113510
- 00118113512
- 00118113514
- 00118114008
- 00118114010
- 00118114012
- 00118114014
- 00118114508
- 00118114510
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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