Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
This recall has been terminated (originally issued March 24, 2017).
- Company
- Arthrex, Inc.
- Recall Initiated
- March 24, 2017
- Terminated
- November 4, 2019
- Recall Number
- Z-2042-2017
- Firm Location
- Naples, FL
- Official Source
- View on FDA website ↗
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)
Lot / Code Info
Unique Device Identifier: 00888867026803 Batch Number: 10078258 Expiration Date 12/01/2021
Root Cause
Under Investigation by firm
Action Taken
On March 24, 2017, Arthrex contacted all distributors that received potentially affected device and instructed them to place the product in quarantine. On March 27th, 2017, Distributors were instructed to return the affected device to Arthrex. Call Arthrex Customer Service at 855-552-5056 for returned goods authorization (RGA) and product return instruction. Please complete the Recall Acknowledge of Receipt postal card included in the notification. Any questions contact Complaints@Arthrex.comor 866-267-9138