Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Check against the official notice below — it lists the full affected range.
Arthrex, Inc. is recalling the Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching anchor because some eyelets broke from the SwiveLock Anchor during insertion. The affected product has a Unique Device Identifier of 00888867026926, Batch Number 10072597, with an expiration date of 10/31/2021. This product was distributed across all U.S. states and territories, as well as multiple countries including Canada, Australia, Germany, Japan, and others.
The recall record does not specify a remedy or course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Some eyelets broke from SwiveLock Anchor on insertion.
Reason for recall: Some eyelets broke from SwiveLock Anchor on insertion. Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD) Quantity: N/A Lot/code info: Unique Device Identifier: 00888867026926 Batch Number: 10072597 - Expiration Date 10/31/2021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.