CLASS II Device recall · Reported 26 Jun 2019 · FDA Enforcement Report
2.7 Degree Angled Sagittal Saw attachment recalled by Mako Surgical
Mako Surgical is recalling 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only), distributed in 13 states. The recall was initiated on 25 Apr 2019 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-1823-2019
- FDA event ID
- 82738
- Recalling firm
- Mako Surgical, Davie, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2019
- FDA classified
- 15 Jun 2019
- Reported
- 26 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 25 Apr 2019 | Recall initiated by company | |
| 15 Jun 2019 | Classified by FDA | +51 days |
| 26 Jun 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The bearings of the saw attachments were ungreased.
Product as listed by the FDA
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Where it was distributed
AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
ArkansasCaliforniaFloridaKansasMassachusettsMissouriNorth CarolinaNew JerseyNew YorkOhioOregonTennesseeTexas
Questions about this recall
Why was it recalled?
The bearings of the saw attachments were ungreased.
Which lots are affected?
Catalog Number: 212480 Lot Number: 35040918 UDI: (01)00848486032128(10)35040918
Where was it sold?
AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 82738| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 2.7 Degree Straight Sagittal Saw attachment recalled by Mako Surgical | Mako Surgical | Other | 13 states |
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 | Makoplasty RIO Standard System recalled by Mako Surgical | Mako Surgical | Other | Nationwide |
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 | Device Malfunction | 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) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |