Z-2222-2025Class II

Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3)...

Name: Z-2222-2025 Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3)...
Creator: Osteotec Limited
Published: 2025-06-18
License: https://open.fda.gov/license/

Osteotec Limited / initiated 2025-06-18 / Open, Classified

FDA source

Osteotec Limited began a recall of 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... on 2025-06-18. FDA classified it as Class II and gives the reason as "There is the potential that the silicone implant may contain foreign material". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2222-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-18
Posted: 2025-07-31
Recalling firm: Osteotec Limited
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
Product code: KYJ Prosthesis, Finger, Constrained, Polymer
Reason for recall: There is the potential that the silicone implant may contain foreign material
FDA root cause: Process change control
Action: On June 18, 2025, Osteotec issued an Urgent Medical Device Recall Notification via E-Mail. Osteotec asked consignees to take the following actions: 1. Immediately review your inventory and quarantine any of the affected LOTs. 2. If a physician has successfully implanted the device, they physician should continue to monitor the implant for any infections or issues. If a physician has successfully implanted a device that potentially could contain foreign material, it is recommended that they continue to monitor the patient for any infections or issues associated with the recalled device. 3. Share this Product Recall letter within your facility network and forward to any customers to whom you have distributed products from the affected LOTs to ensure awareness. 4. Complete and return the attached response and acknowledgement form to Osteotec. 5. Return affected products to your Agent/Distributor/Osteotec
Quantity in commerce: 15573 units
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2222-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2222-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31

Product code KYJ

K140453Class IIOsteotec Silicone Finger ImplantOsteotec, Ltd. / cleared 2015-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)