2.7 Degree Straight Sagittal Saw attachment (Mako Total… recallZ-1824-2019 · Mako Surgical Corporation · initiated Apr 25, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mako Surgical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The bearings of the saw attachments were ungreased.
FDA root cause category: Under Investigation by firm
What the company is doing
On April 25, 2019, URGENT MEDICAL DEVICE RECALL letters under Stryker's letterhead were sent to their US consignees advising them of the issue, potential harm. This letter instructed their consignees to inform users of this device of the recall, requested that they complete the enclosed URGENT MEDICAL DEVICE RECALL BUSNESS REPLY FORM, and return all recalled product to Stryker. Actions to be taken by the Customer/ User: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-877-496-5040 or email to [email protected] 3. Hospitals/Branches/Agencies: Return all affected instruments available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07431 Ref. PFA 1958828
Recall details
- Recall number
- Z-1824-2019
- Status
- Terminated
- Initiated by the company
- Apr 25, 2019
- Recalling firm
- Mako Surgical Corporation
- Quantity
- 7
- Product code
- OLO
- FDA submissions
- K143752
- Distribution
- AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
Product description
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
Code information (models, lots, serial numbers)
Catalog Number: 212186 Lot Number: 35051018 and 35050918 UDI: (01)00848486032111(10)35051018 and (01)00848486032111(10)35050918
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 212186Mako Surgical Corp. · Orthopedic stereotaxic instrument1 recall153 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 82738).
- Z-1823-2019 · Terminated2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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