2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Recall
- Recall Number
- Z-1823-2019
- Event Number
- 82738
- Firm
- Mako Surgical Corporation
- FEI Number
- 3005985723
- Product Code
- OLO
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 25, 2019
- Terminated
- April 22, 2021
- Address
- 2555 Davie Rd, Ste 110, Davie, FL, 33317-7424
Description
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
The bearings of the saw attachments were ungreased.
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
AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
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