Smith&Nephew SmartStitch PerfectPasser Connector — Class II medical device recall Z-3000-2020
Terminated recall by ArthroCare Corporation, reported 2020-09-30, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensio
| Recall number | Z-3000-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ArthroCare Corporation, Austin, TX, United States |
| Recall initiated | 2019-02-21 |
| Classified | 2020-09-21 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2022-08-17 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE, AT, BE, CA, CH, DE, DK, FR, GB, IE, IN, NL, NO, PL, RU, SG, TR, ZA |
| Quantity | 15,559 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00817470006971 |
| Lot numbers | 1154857, 1154858, 1156429, 1165209, 1166194, 1168946, 1170928, 1170929, 1170930, 1170931, 1174530, 1174531, 1175357, 1175401, 1178577, 1178578, 1179854, 1179855, 1179856, 1179857, 1179858, 1179859, 1181657, 1181658, 1182577, 1182578, 1182579, 1182580, 1182581, 1182621, 1182622, 1184074, 1184075, 1184076, 1184077, 1184078, 1184825, 1184826, 1184827, 1184828 and 38 more |
| Model numbers | OM-8010 |
Product
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
Reason for recall
The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.
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-3000-2020. 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.