# FDA recall Z-2506-2021

> **In2bones USA, LLC** · Class II · device recall initiated 2021-08-18.

## Product

CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.

## Reason for recall

Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.

## Distribution

US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, LA, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, VA, and WI.  There was no military/government distribution.

## Key facts

- **Recall number:** Z-2506-2021
- **Recalling firm:** In2bones USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-18
- **Report date:** 2021-09-29
- **Termination date:** 2023-08-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2506-2021

## Citation

> AI Analytics. FDA recall Z-2506-2021. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-2506-2021. Source: US FDA. Licensed CC0.

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