# FDA recall Z-3000-2020

> **ArthroCare Corporation** · Class II · device recall initiated 2019-02-21.

## 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.

## Distribution

US: 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,  ON,  OR,  PA,  SC,  SG,  TN,  TX,  UT,  VA,  WA,  WI, WV    OUS: Austria, Belgium, Canada, Switzerland, Germany, Denmark, France, England, Ireland, India, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, Turkey, United Arab Emirates, South Africa)

## Key facts

- **Recall number:** Z-3000-2020
- **Recalling firm:** ArthroCare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-21
- **Report date:** 2020-09-30
- **Termination date:** 2022-08-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3000-2020

## Citation

> AI Analytics. FDA recall Z-3000-2020. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-3000-2020. Source: US FDA. Licensed CC0.

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