TriMed Ulnar Osteotomy Compression Plate Recalled for Manufacturing Defect
TriMed Inc. is recalling 722 Ulnar Osteotomy Compression Plates because instrument holes are located on the wrong side of the plate.
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 defect involves a structural error in a surgical implant that could lead to improper procedure execution, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TriMed Inc. is recalling 722 units of the Ulnar Osteotomy Compression Plate, Short Model (UOCP-S). The recall affects Lot Numbers 10003 and 10017. These medical devices are intended for use in osteotomy procedures of the ulna and are provided non-sterile with required fixation screws and surgical instrumentation.
The recall was initiated because two instrument holes located on the side of the plate, which act to align the saw guide, are located on the wrong side of the plate. This manufacturing defect may affect the proper alignment of the saw guide during surgical procedures.
The affected products were distributed worldwide, specifically in the state of Texas and in the countries of Australia, China, and Sweden. Healthcare providers and patients who have used or may use these specific lots should contact TriMed Inc. for further instructions on how to proceed.
The recalled product
- Product
- Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
- Manufacturer
- TriMed Inc.
- Affected units
- 722
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)
- Lot Numbers: 10003
- 10017
Distribution
Distributed in 1 state:
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