device · product 1 of 6
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
- Recall number
- Z-2041-2017
- Initiated
- March 24, 2017
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Arthrex, Inc.
- Quantity
- N/A
App-derived interpretation
Some eyelets broke from SwiveLock Anchor on insertion.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
Reason for recall
Some eyelets broke from SwiveLock Anchor on insertion.
Code information
Unique Device Identifier: 00888867026766 Batch Number: 1078259 Expiration Date 11/30/2018
Distribution pattern
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)