Osteotec silicone finger implants may contain foreign material
Osteotec Silicone Finger Implants in sizes 3, 4 and 5 are being recalled because there is the potential that the silicone implant may contain foreign material. 15,573 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm product: foreign material may be present in an implant intended to remain in the body, with no injury reported in the source.
Plain-English summary
The Osteotec Silicone Finger Implant, catalog numbers OSTF-3, OSTF-4 and OSTF-5, is being recalled. The action covers 15,573 units, with lots including 127707 and 127708 expiring 07/17/2028.
The stated reason is that there is the potential that the silicone implant may contain foreign material. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was nationwide in the United States, in California. The implants are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog numbers, lot numbers and UDI-DI codes above, quarantine it, and follow the instructions issued by the manufacturer.
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…
- Manufacturer
- Osteotec Limited
- Affected units
- 15,573
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
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