The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2604-2014·Announced 2014-09-17

Wright Medical Recalls CLAW II Orthopedic Plates Due to Incorrect Raw Material

Wright Medical Technology is recalling 178 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall involves a medical device with a manufacturing defect (incorrect raw material) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Wright Medical Technology, Inc. is recalling 178 units of the CLAW II 2 Hole Plate Ortholoc 3DSi, length 30mm, reference 40240230. These orthopedic plates are prescription-only and non-sterile. The recall was initiated because the plates were manufactured from an incorrect raw material.

The affected lots are 1487670, 1487671, 1487672, 1512149, 1519496, 1523745, 1534796, 1537159, 1539400, and 1540714. The products were distributed nationwide in the United States and internationally to Canada, Australia, Great Britain, Germany, Spain, the Netherlands, and France.

Healthcare providers and patients should check their inventory and records for these specific lot numbers. If the product is in use, contact Wright Medical Technology for instructions on removal or replacement. The source text does not report any specific injuries or illnesses associated with this recall.

The recalled product

Product
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Manufacturer
Wright Medical Technology, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
178

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 (10)

  • Lot Numbers: 1487670
  • 1487671
  • 1487672
  • 1512149
  • 1519496
  • 1523745
  • 1534796
  • 1537159
  • 1539400
  • 1540714

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

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