Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Check against the official notice below — it lists the full affected range.
Arthrex, Inc. is recalling the SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm due to eyelets breaking from the SwiveLock Anchor during insertion. The affected implants were distributed across the United States, Puerto Rico, and multiple international locations including Canada, Australia, and Japan. The recalled devices are identified by unique device identifier 00888867027329 and include eight specific batch numbers with expiration dates ranging from December 2017 to November 2018.
The recall source does not specify a remedy or corrective 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: 00888867027329 Batch Number: 10072597 - Expiration Date 10/31/2018 Batch Number: 10074288 - Expiration Date 10/31/2018 Batch Number: 10076753 - Expiration Date 10/31/2018 Batch Number: 10076852 - Expiration Date 10/31/2018 Batch Number: 10081420 - Expiration Date 11/30/2018 Batch Number: 10075965 - Expiration Date 10/31/2018 Batch Number: 10077252 - Expiration Date 10/31/2018 Batch Number: 10084027 - Expiration Date 12/31/2017
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.