# FDA recall Z-1147-2020

> **Stryker Corporation** · Class II · device recall initiated 2019-07-19.

## Product

Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197

## Reason for recall

Complaints have been received regarding difficulty in removing the driver from the screw.  High driver removal forces can lead to the screw pulling out still attached to the driver. This could result  in an additional anchor insertion site in the bone being used.

## Distribution

US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI

## Key facts

- **Recall number:** Z-1147-2020
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-19
- **Report date:** 2020-02-19
- **Termination date:** 2024-02-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1147-2020

## Citation

> AI Analytics. FDA recall Z-1147-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1147-2020. Source: US FDA. Licensed CC0.

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