The Recall Desk
HighFDA (Devices)·Z-2222-2025·Announced 2025-08-06

Osteotec Silicone Finger Implant Recalled Due to Potential Foreign Material

Osteotec Limited is recalling approximately 15,573 Osteotec Silicone Finger Implants due to potential foreign material contamination. The affected models are OSTF-3, OSTF-4, and OSTF-5.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with potential foreign material contamination and no reported illnesses or injuries. This qualifies as a risk-of-harm product where injury has not yet been reported, warranting High severity per the rubric.

Plain-English summary

Osteotec Limited is recalling the Osteotec Silicone Finger Implant, available in three sizes (OSTF-3, OSTF-4, and OSTF-5). These sterile, flexible silicone elastomer implants are designed for use in finger joint replacement surgery, specifically for metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The recall affects approximately 15,573 units distributed in the United States.

The implants are being recalled because of the potential that the silicone implant may contain foreign material. The presence of such contamination could impact the performance and safety of the implant.

Patients who have received these implants should contact their healthcare provider to discuss whether they may have received an affected implant and what steps should be taken. Healthcare providers should review their records and contact Osteotec Limited for information about replacements, further guidance, and recall status.

The recalled product

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 implan
Manufacturer
Osteotec Limited
Category
Medical Device — Surgical Implants
Hazard
  • foreign-material

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot Code: OSTF-3 LOT 127707 Exp 07/17/2028
  • UDI-DI:5060183090040 OSTF-4 LOT 127708 Exp 07/17/2028
  • UDI-DI:5060183090057 OSTF-5 LOT 127709 Exp 07/17/2028
  • UDI-DI:5060183090064

Distribution

Distributed nationwide across the United States.

Related recalls

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