The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2608-2014·Announced 2014-09-17

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

Wright Medical Technology is recalling 50 units of CLAW II Straight Plates 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences are categorized as Severe (Score 4), as they are not Class I (Critical) but involve a risk of harm.

Plain-English summary

Wright Medical Technology, Inc. is recalling 50 units of CLAW II Straight Plate Ortholoc 3DSi (REF 40242025). The recall involves specific lot numbers: 1513144, 1518479, 1534798, 1538331, and 1543489. The product is a non-sterile, prescription-only orthopedic implant.

The recall was initiated because the plates were manufactured from an incorrect raw material. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected units were distributed nationwide in the United States and internationally to Canada, Australia, Great Britain, Germany, Spain, the Netherlands, and France. Healthcare providers and patients who have received these specific implants should contact Wright Medical Technology or their healthcare provider for instructions on removal or replacement.

The recalled product

Product
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Manufacturer
Wright Medical Technology, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
50

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 (5)

  • Lot Numbers: 1513144
  • 1518479
  • 1534798
  • 1538331
  • 1543489

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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