FDA Device recall Z-2046-2017
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
- FDA Device
- Class II
- terminated
- Published 2017-05-17
On 2017-05-17 the FDA classified a Class II recall of Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching by Arthrex, citing some eyelets broke from SwiveLock Anchor on insertion.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2046-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-24 |
| Published | 2017-05-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arthrex |
| 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, PR, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Reason
Some eyelets broke from SwiveLock Anchor on insertion.
Identifiers
| code_info | Unique Device Identifier: 00888867160231 Batch Number: 10070003 - Expiration Date 9/30/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2046-2017%22
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