Anthrex Bio Composite 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 Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching anchor device because eyelets broke from the SwiveLock Anchor during insertion in some units. The affected product was distributed across all U.S. states, Puerto Rico, and multiple international locations including Canada, Australia, Japan, and various European and other countries. The affected devices are identified by Unique Device Identifier 00888867026865 and include five specific batch numbers with expiration dates ranging from October 31, 2018 to November 30, 2018.
The recall notice does not specify a remedy or recommended action for consumers who may have this 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: 00888867026865 Batch Number: 10072425 - Expiration Date 10/31/2018 Batch Number: 10073992 - Expiration Date 10/31/2018 Batch Number: 10077133 - Expiration Date 10/31/2018 Batch Number: 10078077 - Expiration Date 11/30/2018 Batch Number: 10078340 - Expiration Date 11/30/2018 Batch Number: 10075792 - Expiration Date 10/31/2018
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.