Howmedica Osteonics recalls certain Mako Restoris MCK Baseplate Trials (Size 6) due to incorrect laser marking that may affect surgical accuracy. Affected units include specific lot numbers and reference codes.
“Howmedica Osteonics recalls Mako Restoris MCK Baseplate Trial (Size 6) with incorrect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58761-howmedica-osteonics-recalls-mako-restoris-mck-baseplate-trial-size-6. Based on FDA recall #Z-1386-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1386-2023%22&limit=1).
The FDA announced on March 10, 2023, that Howmedica Osteonics Corp. is recalling stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL) units due to incorrect size laser marking. The agency issued the voluntary Class II recall for devices distributed in the U.S., Netherlands, Japan, China, India, Korea, and Australia.
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking. The recall involves 102 units intended for use in a Partial Knee Arthroplasty surgical procedure.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Recent brand recalls include the OMNIFIT Series I Acetabular Insert Recall (July 30, 2026) and the Triathlon Baseplate Size 4 Recall (May 19, 2026). Other recent recalls of similar products include EMPOWR 3D KNEE Implants Have Incorrect Labeling (Jan. 15, 2026), Think Surgical TMINI Tracking Arrays: Risk of Misalignment Due to Loose Knob (May 8, 2026), and Medline Recalls Knee Surgery Kits Due to Sterility Risk (June 10, 2026).
How to tell if you have this one
Check for the product name 'Mako Restoris MCK Baseplate Trial (Size 6 RM/LL)', reference number '170616', and lot number '26250421'. The product was sold with GTIN 00848486003753.
Brand
Howmedica
Product
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
U.S., Netherlands, Japan, China, India, Korea, and Australia.
Recall number
Product, codes & lots
Quantity
Z-1385-2023
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure; GTIN 00848486003746, Lot Number 26270421
52 units
Z-1386-2023
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure; GTIN 00848486003753, Lot Number 26250421
102 units
Based on the official FDA remedy
What to do — step by step
Verify Product Details
Check the product's reference number (170616) and lot number (26250421) to confirm if it is affected.
How this recall unfolded
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1386-2023 (March 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1386-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.