Reported Mar 9, 2016 · Terminated
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee…
Mako Surgical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mako Surgical Corporation · 2555 Davie Rd Ste 110 · Plantation, FL · 33317-7424
Is this the product you have?
- Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 180615Lot # 26141111-01 Catalog # 180611 - Lot #'s 26131111-01 and 26050211-01 Catalog # 180612 - Lot #'s 26190911-01, 36010112-1, 26070212-01, 26410611-01, 26020411-01, and 26060211-01 Catalog # 180613 Lot #'s 26271011-01 and 26240711-01 Catalog # 180614 - Lot #'s 36031211-1, 26180512-01, 26440611-01, and 26190612-01 180617Lot # 2610012-01 Catalog # 180616 Lot #'s 26160212-01, 2634012-01, 26300811-01, 26171111-01, 26350512-01, and 26310612-01. Lot #'s 26310412-01, 26160711-01, 26210511-02, 26061011-01, 26061011-01, and 180618LOT1388810512. Lot #'s: 26360512-01, 26060311-01, and 26061211-01. - Amount recalled
- 146
Where it was sold
Why it was recalled
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.