Knee implant trial components recalled for incorrect size laser markings
Stryker MAKO RESTORIS MCK tibial baseplate trial components used in knee surgery contain incorrect laser markings indicating component size. This affects 52 units distributed internationally and could lead to implantation of wrong-sized components during surgery.
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: This is a Class II recall involving incorrect size markings on surgical implant trial components. The incorrect laser markings create a risk that surgeons may inadvertently implant wrong-sized components during knee replacement surgery, which could compromise surgical outcomes.
Plain-English summary
The FDA is recalling certain lots of Stryker MAKO RESTORIS MultiCompartmental Knee (MCK) Tibial Baseplate Trial components (Size 5 RM/LL, Reference 170615, Lot 26270421) used in partial knee replacement surgery. These trial components are intended for use by surgeons to test implant fit and positioning during knee arthroplasty procedures.
The recalled components contain incorrect size laser markings. If the laser marking does not correspond to the actual component size, surgeons may inadvertently select or implant the wrong-sized component during surgery.
Fifty-two units have been identified and distributed to surgical centers in the United States, Netherlands, Japan, China, India, Korea, and Australia. Healthcare providers who received these components should verify the actual component dimensions match the laser marking before use in any surgical procedure. Surgeons and surgical staff should discontinue use of Lot 26270421 immediately and contact Howmedica Osteonics Corp. for replacement components.
The recalled product
- Product
- stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 52
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 (2)
- GTIN 00848486003746
- Lot Number 26270421
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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