Orthopedic Bone Fixation Plates Recalled for Incorrect Product Packaging
Wright Medical Technology recalls ORTHOLOC 3DSi CLAW II bone fixation plates due to incorrect products placed in packages. Healthcare providers should verify product identification matches packaging before use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (surgical bone fixation device) where incorrect product packaging could result in the wrong implant being used during surgery. Per the rubric, risk-of-harm products are classified as High (3).
Plain-English summary
Wright Medical Technology, Inc. is recalling ORTHOLOC 3DSi CLAW II 4 HOLE bone fixation plates (Size 25MM, REF 402S0425, Lot Number 1636048, GTIN 00840420152985) due to incorrect product packaging. During manufacturing, two specific lots of plates were comingled, resulting in wrong products being placed in packages. Packaging labeled for REF 402S0425 incorrectly contained REF 40241425, and vice versa.
The recall affects 10 units that were distributed in New York.
Healthcare providers and institutions that received affected units should immediately verify that the product in the package matches the package label. Contact Wright Medical Technology, Inc. for product replacement or clarification if any discrepancy is found. Do not use any product where the contents do not match the label.
The recalled product
- Product
- ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 10
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 (2)
- GTIN 00840420152985
- Lot Number 1636048
Distribution
Part of a larger recall action
This product is one of 2 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.
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