The Recall Desk
ModerateFDA (Devices)·Z-0566-2020·Announced 2019-12-04

Wright Medical Recalls Valor Screws Due to Sterility Documentation Issues

Wright Medical Technology is recalling 54 units of Valor Screws because adequate documentation confirming sterility was missing.

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, but the source text identifies the issue as a documentation deficiency regarding sterility confirmation rather than a confirmed contamination or reported injury, aligning with the rubric for moderate severity.

Plain-English summary

Wright Medical Technology, Inc. is recalling 54 units of VALOR SCREW 5.0MM X 45MM LEN (Part Number 4151150045). The recall was initiated after the firm discovered a lack of adequate documentation confirming the sterility of these specific products.

The affected products, identified by Lot Number 1547961, were distributed in the United States and internationally to Norway, Italy, Germany, France, South Africa, the UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, and Spain.

Consumers and healthcare providers should stop using these specific units and contact Wright Medical Technology for instructions on return or replacement.

The recalled product

Product
VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045
Affected units
54

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 (1)

  • Lot Number 1547961

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 12 recalled by Wright Medical Technology, 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.

See all 12 products in this recall →