Arthrex Suture Washer Recalled Due to Incorrect Assembly
Arthrex, Inc. is recalling 45 Suture Washers because the suture and washer were not assembled and were placed loose in the package.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The defect is a packaging/assembly issue without reported injuries.
Plain-English summary
Arthrex, Inc. is recalling 45 units of the Arthrex Suture Washer. The recall is due to a manufacturing error where the device was assembled incorrectly. Specifically, the suture and washer components were not assembled together and were instead placed loose within the package.
The affected devices are identified by the Unique Device Identifier (UDI) 00888867118607, Catalog # AR-7000-18T, and Batch #10028617. The source text indicates that these devices were distributed to locations in New York, Minnesota, Kentucky, California, Idaho, Colorado, Massachusetts, and Florida, as well as Thailand.
No specific instructions for consumers or healthcare providers are provided in the source text regarding how to handle the recalled devices. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Arthrex Suture Washer
- Manufacturer
- Arthrex, Inc.
- Hazard
- Affected units
- 45
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 (3)
- Unique Device Identifier (UDI): 00888867118607
- Catalog # AR-7000-18T
- Batch #10028617.
Distribution
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