# FDA recall Z-2160-2019

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2019-06-18.

## Product

Serrato 9.5mm X 90mm Polyaxial Screw  Catalog Number 482619590  Serrato 9.5mm X 100mm Polyaxial Screw  Catalog Number 4826195100

## Reason for recall

Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.

## Distribution

US Nationwide Distribution - CA, FL,  GA, MA,  NY, PA, TX

## Key facts

- **Recall number:** Z-2160-2019
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-18
- **Report date:** 2019-08-14
- **Termination date:** 2020-05-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2019

## Citation

> AI Analytics. FDA recall Z-2160-2019. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-2160-2019. Source: US FDA. Licensed CC0.

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