# FDA recall Z-1463-2018

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2017-12-20.

## Product

The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling:    Catalog Number	Product Description  TRL092002506	Humeral Stem Trial, 6mm  TRL092002507	Humeral Stem Trial, 7mm  TRL092002508	Humeral Stem Trial, 8mm  TRL092002509	Humeral Stem Trial, 9mm  TRL092002510	Humeral Stem Trial, 10mm  TRL092002511	Humeral Stem Trial, 11mm  TRL092002512	Humeral Stem Trial, 12mm  TRL092002513	Humeral Stem Trial, 13mm  TRL092002514	Humeral Stem Trial, 14mm  TRL092002515	Humeral Stem Trial, 15mm  TRL092002516	Humeral Stem Trial, 16mm

## Reason for recall

Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.

## Distribution

Worldwide Distribution - USA (nationwide) Distribution.

## Key facts

- **Recall number:** Z-1463-2018
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-20
- **Report date:** 2018-05-02
- **Termination date:** 2020-02-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1463-2018

## Citation

> AI Analytics. FDA recall Z-1463-2018. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1463-2018. Source: US FDA. Licensed CC0.

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