Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Check against the official notice below — it lists the full affected range.
Arthrex, Inc. is recalling the Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching due to eyelets breaking from the SwiveLock Anchor during insertion. The affected product has Unique Device Identifier 00888867160231, Batch Number 10070003, with an expiration date of 9/30/2021. The product was distributed across all U.S. states and territories, as well as multiple countries including Canada, Australia, Germany, Japan, and others.
The recall source does not specify a remedy for affected consumers or what actions they should take regarding this recalled product.
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: 00888867160231 Batch Number: 10070003 - Expiration Date 9/30/2021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.