Wright Medical Recalls Orthopedic Claw Plates Due to Incorrect Raw Material
Wright Medical Technology is recalling specific orthopedic claw 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 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 is classified as FDA Class II, and the source text does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Wright Medical Technology, Inc. is recalling the CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM (REF 40S20020). The recall is being conducted because the plates were manufactured from an incorrect raw material.
The affected product is a non-sterile, prescription-only orthopedic device. The specific lot number involved is 1543488. The source text does not specify the total quantity of units recalled or the specific dates of manufacture.
The product was 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 this specific device should contact their healthcare provider or Wright Medical Technology for further instructions.
The recalled product
- Product
- CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
- Manufacturer
- Wright Medical Technology, Inc.
- Category
- Medical Device — Orthopedic
- Hazard
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: 1543488
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 →Related recalls
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