# FDA recall Z-0373-2019

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2018-09-10.

## Product

Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries.

## Reason for recall

Potential for outer pouch sterile barrier to be compromised

## Distribution

US Nationwide in the states of AL, FL, IL, MI, NJ & OH.

## Key facts

- **Recall number:** Z-0373-2019
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-10
- **Report date:** 2018-11-14
- **Termination date:** 2020-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0373-2019

## Citation

> AI Analytics. FDA recall Z-0373-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0373-2019. Source: US FDA. Licensed CC0.

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