Restoris MCK Onlay Insert Extractor.
Reported: June 13, 2018 Initiated: January 19, 2018 #Z-2051-2018
Product Description
Restoris MCK Onlay Insert Extractor.
Reason for Recall
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Details
- Recalling Firm
- Mako Surgical Corporation
- Units Affected
- 575 units total (400 US, 175 OUS)
- Distribution
- Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.
- Location
- Davie, FL
Frequently Asked Questions
What product was recalled? ▼
Restoris MCK Onlay Insert Extractor.. Recalled by Mako Surgical Corporation. Units affected: 575 units total (400 US, 175 OUS).
Why was this product recalled? ▼
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2051-2018.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11