RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Reported: May 16, 2018 Initiated: December 1, 2017 #Z-1644-2018
Product Description
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Reason for Recall
Incorrect product and/or label. Sizing is labeled incorrectly.
Details
- Recalling Firm
- Mako Surgical Corporation
- Units Affected
- 126
- Distribution
- AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam
- Location
- Davie, FL
Frequently Asked Questions
What product was recalled? ▼
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.. Recalled by Mako Surgical Corporation. Units affected: 126.
Why was this product recalled? ▼
Incorrect product and/or label. Sizing is labeled incorrectly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1644-2018.
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