Wright Medical Recalls 3.5mm Claw Plates Due to Incorrect Raw Material
Wright Medical Technology is recalling 9 units of CLAW 3.5mm 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 hazard involves a structural defect (incorrect raw material) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Wright Medical Technology, Inc. is recalling 9 units of the CLAW 3.5mm Plate Charlotte F&A System, Size 30mm, 2 Hole, Reference 4013-0130. The recall is due to the plates being manufactured from an incorrect raw material.
The affected units are identified by Lot Number 1509955. These orthopedic plates are prescription-only and non-sterile. The distribution pattern includes nationwide distribution in the United States and international distribution to Canada, Australia, Great Britain, Germany, Spain, the Netherlands, and France.
Healthcare providers and patients should contact Wright Medical Technology for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 9
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: 1509955
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.
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