Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Check against the official notice below — it lists the full affected range.
Arthrex, Inc. is recalling Anthrex PEEK SwiveLock SP Vented anchors (5.5mm x 24.5mm, self-punching) because some eyelets broke from the SwiveLock Anchor during insertion. The affected product has Unique Device Identifier 00888867026803, Batch Number 10078258, and an expiration date of December 1, 2021. The product was distributed across all U.S. states, Puerto Rico, and multiple countries including Canada, Australia, Germany, Japan, India, and others.
The recall notice does not specify a remedy or instructions for what consumers should do with affected devices.
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: 00888867026803 Batch Number: 10078258 Expiration Date 12/01/2021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.