Anthrex Bio-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 Bio-SwiveLock SP Vented anchors (5.5mm x 24.5mm, self-punching) with batch number 1078259 and expiration date 11/30/2018 due to a defect where eyelets broke from the SwiveLock Anchor during insertion. The affected devices were distributed across all U.S. states and territories, as well as multiple international locations including Canada, Australia, and several European countries.
The record does not specify a remedy or instructions for what affected consumers should do regarding this recall.
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: 00888867026766 Batch Number: 1078259 Expiration Date 11/30/2018
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.