—#199205

Product

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

FDA product code: HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K082172, K090763
Affected lot / code info: GTIN 00848486003746, Lot Number 26270421

Why it was recalled

Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

Root cause (FDA determination)

Process change control

Action the firm took

Stryker issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/10/2023 by letter. The notice explained the issue and the hazard and requested the following actions be taken: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the affected products in Table 1. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to strykerortho5321@sedgwick.com/ fax (888) 266-7910. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return ALL affected product to: Stryker Orthopaedics/PFA Product Return. Stryker issued an URGENT MEDICAL DEVICE RECALL UPDATE notice to its consignees on 04/12/2023. The letter contained the same information, but added a section titled Recommendations for patients already treated with an affected device, and advised patients treated with an affected product should continue to be followed per the normal protocol established by his or her surgeon(s).

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: U.S., Netherlands, Japan, China, India, Korea, and Australia.

Timeline

Recall initiated: 2023-03-10
Posted by FDA: 2023-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199205. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.