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U.S. Department of Health and Human Services

Class 2 Device Recall Osteotec Silicone Finger Implant

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 Class 2 Device Recall Osteotec Silicone Finger Implantsee related information
Date Initiated by FirmJune 18, 2025
Date PostedJuly 31, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2222-2025
Recall Event ID 97126
510(K)NumberK140453 
Product Classification Prosthesis, finger, constrained, polymer - Product Code KYJ
ProductBrand 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
Code Information 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
FEI Number 3008395366
Recalling Firm/
Manufacturer		 Osteotec Limited
Unit 9
Silver Business Park; Airfield Way
Christchurch United Kingdom
For Additional Information ContactTimothy Allard
0-1202 487885
Manufacturer Reason
for Recall		There is the potential that the silicone implant may contain foreign material
FDA Determined
Cause 2		Process change control
ActionOn 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 Commerce15573 units
DistributionUS Nationwide distribution in the state of CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KYJ
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