TriMed Recalls Olecranon Hook Plates Due to Unqualified Hole Modification
TriMed Inc. is recalling 583 Olecranon Hook Plates because angled holes may have been modified from specifications without full qualification.
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 potential manufacturing defect (unqualified modification) that could affect structural integrity, representing a risk of harm where injury has not yet been reported.
Plain-English summary
TriMed Inc. is recalling 583 units of the Olecranon Hook Plate, Left, 6-Holes (REF: OHOOKL-6). The recalled product is a semi-tubular design bone plate with two offset intramedullary tines intended to penetrate the small terminal fragment to provide additional stabilization. The devices are non-sterile and prescription-only.
The recall was initiated because the firm became aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification. The firm noted that this modification may not have been fully qualified.
The affected units are identified by Lot # 110631. Distribution was nationwide in the United States, specifically in the states of Maryland (MD) and Utah (UT). Healthcare providers and patients should contact TriMed Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide…
- Manufacturer
- TriMed Inc.
- Affected units
- 583
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 # 110631
Distribution
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