Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2222-2025 — 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,

U.S. FDA — Device Enforcement · United Kingdom · 2025-06-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2222-2025
Date of alert: 2025-06-18
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Osteotec Limited
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 5060183090040

Reported risk: There is the potential that the silicone implant may contain foreign material

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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