# FDA recall Z-1237-2024

> **Synthes (USA) Products LLC** · Class II · device recall initiated 2024-01-24.

## Product

RIA Tube Assembly, minimum 520 mm length, sterile-  intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis.  Part Number: 314.746S

## Reason for recall

Products not sterilized, sterility cannot be confirmed

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.

## Key facts

- **Recall number:** Z-1237-2024
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-24
- **Report date:** 2024-03-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2024

## Citation

> AI Analytics. FDA recall Z-1237-2024. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1237-2024. Source: US FDA. Licensed CC0.

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