FDAFDA · Food and drugs·Recall number Z-2042-2017
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Published May 17, 2017 · Recall initiated: March 24, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some eyelets broke from SwiveLock Anchor on insertion.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arthrex, Inc.
- Distributor
- 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)
- Lot
- Unique Device Identifier: 00888867026803 Batch Number: 10078258 Expiration Date 12/01/2021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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