The Recall Desk
HighFDA (Devices)·Z-1170-2023·Announced 2023-03-08

Bone fixation plates recalled due to product packaging mix-up

Wright Medical Technology is recalling ORTHOLOC 3DSi CLAW II bone fixation plates due to packaging mix-up in specific lots. Packages contained incorrect product codes.

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: FDA Class II medical device recall without reported injuries or adverse events. The packaging mix-up creates a risk-of-harm scenario where incorrect bone fixation implants could be used in orthopedic surgery, but no injuries have been reported, meeting the rubric criterion for High severity.

Plain-English summary

Wright Medical Technology, Inc. is recalling ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM (REF 40241425), a bone fixation device. Lot Number 1636042 is affected by this recall and has been distributed nationwide in New York.

The recall was initiated due to a packaging mix-up during manufacturing. Two specific lots of CLAW II plates became comingled, causing incorrect products to be placed in packages. Packaging labeled for product code 402S0425 incorrectly contained product code 40241425, and packages for 40241425 contained 402S0425 instead.

The recalled product

Product
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Manufacturer
Wright Medical Technology, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • product-mix-up
  • incorrect-packaging
  • surgical-device-mismatch

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 00840420110770
  • Lot Number 1636042

Distribution

Distributed nationwide across the United States.

Related recalls

Same category