Arthrex Deltoid Ligament Implant Recalled for Potential Sterility Issue
Arthrex is recalling 117 Deltoid Ligament Reconstruction Implant Systems because a component may not be sterile.
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 potential sterility failure in a medical implant, which presents a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Arthrex, Inc. is recalling 117 units of the Deltoid Ligament Reconstruction Implant System. The recall is due to a potential issue where a component contained in the implant system may be non-sterile.
The affected devices are identified by Unique Device Identifier 00888867131446, Catalog No. AR-8918CP, and Batch No. 10020303. These implants are intended to be used as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
The devices were distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI. Healthcare providers and patients should contact Arthrex, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
- Manufacturer
- Arthrex, Inc.
- Hazard
- Affected units
- 117
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: 00888867131446
- Catalog No.: AR-8918CP
- Batch No.: 10020303.
Distribution
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