Arthrex Recalls Sterile Low Profile Titanium Bone Screws Due to Length Error
Arthrex, Inc. is recalling 28 units of sterile low profile titanium bone screws because the screws are 5mm shorter than intended.
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 structural defect in a medical device intended for internal bone fixation, which poses a risk of harm if used, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Arthrex, Inc. is recalling 28 units of Sterile Low Profile Screw, Titanium, 6.7 x 65mm (Part Number: AR-8967-2865S). The recall is due to a manufacturing error where the screws provided in the packaging are 5mm shorter than the intended length.
The affected product is identified by Batch Number 10706233 and UDI Number 00888867056411. These medical devices are intended to be used as stand-alone bone screws or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions.
The affected units were distributed internationally in Denmark, the United Kingdom, Sweden, Japan, and the Netherlands. Healthcare providers and facilities should stop using the affected product and contact Arthrex, Inc. for instructions on return or replacement.
The recalled product
- Product
- Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
- Manufacturer
- Arthrex, Inc.
- Affected units
- 28
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)
- Batch Number: 10706233 UDI Number:00888867056411
Distribution
Distribution scope not specified by the agency.
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