CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Restoris Mck Tibial Baseplate-rm/LL used recalled by Mako Surgical
Mako Surgical is recalling Restoris Mck Tibial Baseplate-rm/LL used in unicompartmental knee arthroplasty and knee, distributed in 32 states. The recall was initiated on 1 Dec 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1644-2018
- FDA event ID
- 79585
- Recalling firm
- Mako Surgical, Davie, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Dec 2017
- FDA classified
- 4 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 1 Dec 2017 | Recall initiated by company | |
| 4 May 2018 | Classified by FDA | +154 days |
| 16 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect product and/or label. Sizing is labeled incorrectly.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Where it was distributed
AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam
AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaNorth CarolinaNebraskaNew Hampshire
Questions about this recall
Why was it recalled?
Incorrect product and/or label. Sizing is labeled incorrectly.
Which lots are affected?
Size 2 Item # 180612 Lot # 26080317-01 and Size 7 Item # 180617 Lot # 26150217-01.
Where was it sold?
AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mako Surgical
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stryker USB Converter, Polaris Spectra Camera recalled by Mako Surgical | Mako Surgical | Device Malfunction | AZ, IL |
| Device | CLASS II | Mako Integrated Cutting System (MICS) Handpiece recalled | Mako Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Mako Hip End Effector, Variable Angle recalled by Mako Surgical | Mako Surgical | Other | 8 states |
| Device | CLASS II | 2.7 Degree Straight Sagittal Saw attachment recalled by Mako Surgical | Mako Surgical | Other | 13 states |
| Device | CLASS II | 2.7 Degree Angled Sagittal Saw attachment recalled by Mako Surgical | Mako Surgical | Other | 13 states |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |