Z-1823-2019Class II

2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)

Name: Z-1823-2019 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Creator: Mako Surgical Corporation
Published: 2019-04-25
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2019-04-25 / Terminated

FDA source

Mako Surgical Corporation began a recall of 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) on 2019-04-25. FDA classified it as Class II and gives the reason as "The bearings of the saw attachments were ungreased". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1823-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-25
Posted: 2019-06-16
Terminated: 2021-04-22
Recalling firm: Mako Surgical Corp.
Product: 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: The bearings of the saw attachments were ungreased.
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 39
Distribution: AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
Product codes and lots: Catalog Number: 212480 Lot Number: 35040918 UDI: (01)00848486032128(10)35040918

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1823-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1823-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1824-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15

Product code OLO

K143752Class IITotal Knee Application (TKA)Mako Surgical Corp. / cleared 2015-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)