Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching — Class II medical device recall Z-2046-2017
Terminated recall by Arthrex, Inc., reported 2017-05-17, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Some eyelets broke from SwiveLock Anchor on insertion.
| Recall number | Z-2046-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2017-03-24 |
| Classified | 2017-05-05 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2019-11-04 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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 |
| Countries outside the US | AT, AU, BO, CA, CH, DE, EE, IE, IL, IN, JP, PT, UY, ZA |
| UPC / GTIN / UDI-DI | 00888867160231 |
| Lot numbers | 10070003 |
| Expiration dates | 2021-09-30 |
Product
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Reason for recall
Some eyelets broke from SwiveLock Anchor on insertion.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2046-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.