Class 2 Device Recall 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)

• Date Initiated by Firm: April 25, 2019
• Create Date: June 16, 2019
• Recall Status: Terminated on April 22, 2021
• Recall Number: Z-1823-2019
• Recall Event ID: 82738
• 510(K)Number: K143752
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• Product: 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
• Code Information: Catalog Number: 212480 Lot Number: 35040918 UDI: (01)00848486032128(10)35040918
• Recalling Firm/ Manufacturer: Mako Surgical Corporation; 2555 Davie Rd Ste 110; Davie FL 33317-7424
• For Additional Information Contact: Ms. Loriann Russo; 201-831-5272
• Manufacturer Reason for Recall: The bearings of the saw attachments were ungreased.
• FDA Determined 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 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
• Quantity in Commerce: 39
• Distribution: AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OLO