2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
This recall has been terminated (originally issued April 25, 2019).
- Company
- Mako Surgical Corporation
- Recall Initiated
- April 25, 2019
- Terminated
- April 22, 2021
- Recall Number
- Z-1824-2019
- Quantity
- 7
- Firm Location
- Davie, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The bearings of the saw attachments were ungreased.
Distribution
AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
Lot / Code Info
Catalog Number: 212186 Lot Number: 35051018 and 35050918 UDI: (01)00848486032111(10)35051018 and (01)00848486032111(10)35050918
Root Cause
Under Investigation by firm
Action Taken
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