Medartis Recalls APTUS Ulna Shortening 2.5 Plates Due to Breakage
Medartis, Inc. is recalling 44 APTUS Ulna Shortening 2.5 plates due to three complaints of temporary tension bolt breakage.
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 involves a risk-of-harm product (medical device breakage) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medartis, Inc. is recalling 44 units of the APTUS Ulna Shortening 2.5 plates. These medical devices are indicated for fractures and osteotomies, particularly for the ulna. The recall was initiated because of three complaints regarding the breakage of the temporary tension bolt.
The affected products are identified by Part no. A-2791.05 and lot no. 14125026. The devices were distributed nationwide in the United States, specifically in the states of West Virginia, Illinois, Connecticut, Arizona, and Washington.
Healthcare providers and patients should stop using the affected devices and contact Medartis, Inc. for further instructions on the recall.
The recalled product
- Product
- APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
- Manufacturer
- Medartis, Inc.
- Hazard
- Affected units
- 44
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)
- Part no. A-2791.05
- lot no. 14125026
Distribution
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