# FDA recall Z-0641-2018

> **Allen Medical Systems** · Class II · device recall initiated 2017-10-06.

## Product

Allen Medical Bow Frame Model A-70800.  Surgical platform used to position patients for lumbar spine procedures.

## Reason for recall

The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.

## Distribution

Worldwide distribution.  US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.

## Key facts

- **Recall number:** Z-0641-2018
- **Recalling firm:** Allen Medical Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-06
- **Report date:** 2018-02-28
- **Termination date:** 2019-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Acton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0641-2018

## Citation

> AI Analytics. FDA recall Z-0641-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0641-2018. Source: US FDA. Licensed CC0.

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