# FDA recall Z-2222-2025

> **Osteotec Limited** · Class II · device recall initiated 2025-06-18.

## Product

Brand Name: Osteotec  Product Name: Osteotec Silicone Finger Implant  Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)  Software Version: N/A  Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which  is placed, during arthroplasty, in the proximal and distal intramedullary canals of either  metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the  bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes  to meet various anatomical variations and is supplied sterile.  Component: N/A

## Reason for recall

There is the potential that the silicone implant may contain foreign material

## Distribution

US Nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-2222-2025
- **Recalling firm:** Osteotec Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-18
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Christchurch, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2222-2025

## Citation

> AI Analytics. FDA recall Z-2222-2025. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2222-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*