Mako Surgical Corporation 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Brand
Mako Surgical Corporation
Lot Codes / Batch Numbers
Catalog Number: 212480 Lot Number: 35040918 UDI: (01)00848486032128(10)35040918
Products Sold
Catalog Number: 212480 Lot Number: 35040918 UDI: (01)00848486032128(10)35040918
Mako Surgical Corporation is recalling 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) due to The bearings of the saw attachments were ungreased.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The bearings of the saw attachments were ungreased.
Recommended Action
Per FDA guidance
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 Stryker10077@stericycle.com 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, FL, KS, MA, MO, NJ, NY, NC, OH, OR, TN, TX
Page updated: Jan 10, 2026