# FDA recall Z-1064-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-12-07.

## Product

6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910)    Product Usage:  The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial plateau fractures, SI joint disruptions, Intercondylar femur fractures, Subtalar arthrodesis, and Fixation of pelvis and iliosacral joint.

## Reason for recall

One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

## Distribution

Canada.

## Key facts

- **Recall number:** Z-1064-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-07
- **Report date:** 2018-03-21
- **Termination date:** 2020-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1064-2018

## Citation

> AI Analytics. FDA recall Z-1064-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1064-2018. Source: US FDA. Licensed CC0.

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