Mako Surgical Corporation 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

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

Distribution

As reported by FDA

AR, CA, FL, KS, MA, MO, NJ, NY, NC, OH, OR, TN, TX