FOI release

Cartiva Synthetic Cartilage Toe Implants - FOI Request

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00926

Received 19 August 2026

Published 7 October 2026

Request

We act on behalf of a client in relation to a potential claim for damages with respect to Cartiva Synthetic Cartilage Toe Implants ("the relevant product"), which were inserted into both of our client's feet, as treatment for osteoarthritis. Our client has since required revision surgery. We understand that NICE withdrew guidance (published in 2022) on the relevant product following a recall notice issued by the manufacturer Stryker on 31 October 2024. Please see attached recall notice MHRA reference: 33744394 2024/010/028/601/045 As part of our investigations into a potential damages claim we would be grateful if you would provide such relevant information/documents concerning the Regulation/Registration of the relevant product insofar as it's placing on the UK market is concerned, to include; 1. The Statutory Instrument under which the relevant product was first permitted to be placed on the UK Market (and details of any subsequent/amending Statutory Instruments) 2. The date upon which the relevant product was first registered/notified in the UK and any documents concerning its registration 3. Confirmation of the device classification of the relevant product under the relevant legislation 4. Confirmation of the conformity assessment procedure applicable to the relevant product 5. Details of the relevant Notified Body/UK Approved Body who undertook the original conformity assessment procedure on the relevant product and any subsequent change of Body 6. A copy of any Declaration of Conformity (EC/EU or UK) 7. A copy of any EC/EU Type Examination Certificate and Certificate Number (and any renewal/extension of certificates or amended Certificates) 8. Copies of any Technical Documentation relating to the relevant product 9. Confirmation as to whether there had been any change to the relevant product's Regulatory status since being first placed on the UK market 10. Documents concerning the recall notice/removal of the relevant product from the UK market Please treat this email as a Freedom of Information request.

Response

See attached

Documents

• FOI2026_00926 (redacted).pdf (2.0 MB)

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