Z-1031-2016Class II

Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental...

Name: Z-1031-2016 Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental...
Creator: Mako Surgical Corporation
Published: 2016-01-15
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2016-01-15 / Terminated / root cause: packaging

FDA source

Mako Surgical Corporation began a recall of Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO on 2016-01-15. FDA classified it as Class II and gives the reason as "Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1031-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-15
Posted: 2016-03-01
Terminated: 2019-08-06
Recalling firm: Mako Surgical Corp.
Product: Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Product code: NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: The firm, Stryker Orthopaedics, sent an "Urgent Product Recall" letter dated 1/15/2016 to all their consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to inspect the device packaging as the damage to the sterile barrier may be notice prior to the procedure; do not use the device if the seal or package is breached and complete and return the attached Product Recall Acknowledgment Form within 5 days by e-mail [email protected] or fax at: 888-480-2853. Return all affected products available at your location to: Stryker c/o Stericycle, 2670 Executive Dr., Suite A, Indianapolis, IN 46241, Attn. RA2015-047-Event 5317. If you have any questions, feel free to contact Sr. Director QA at 954-628-0502.
Quantity in commerce: 146
Distribution: Worldwide Distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, LA, MI, MS, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, and WY ; and countries of: Italy, Scotland, Turkey, Greece, Germany, and Singapore.
Product codes and lots: Catalog # 180601 - Lot #'s: 26110111, 26300512-01, 26110112-01, and 26090311-01 Catalog # 180602 - Lot #'s: LET1484311012, 26020812-01, 26220512-01, 26180711-0126120211-01, 26301011-01, 26161111-01, and 26220512-02. Catalog # 180603 - Lot #'s: LET 1388860512, 26010511-01, 26310811-01 and 26050112-01 Catalog # 180604 - Lot #'s: 26090512-01 and 26280412-01 Catalog # 180605 - Lot #'s: 26310512-01, 26270512-01, and 26250511-01 Catalog # 180606 - Lot #'s: LET1464570912, 26300412-01, 26140412-01, and 26050212-01. Catalog # 180607 - Lot #'s: 26211011-01, 26040212-01, 26330512-01, 26090611-02, 26070811-01, LET1406460512, and 26230411-01. Catalog # 180608 - Lot # 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 Catalog # 180615 Lot # 2610012-01 Catalog # 180616 Lot #'s 26160212-01, 2634012-01, 26300811-01, 26171111-01, 26350512-01, and 26310612-01. Catalog # 180617 Lot #'s 26310412-01, 26160711-01, 26210511-02, 26061011-01, 26061011-01, and LOT1388810512. Catalog # 180618 Lot #'s: 26360512-01, 26060311-01, and 26061211-01.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1031-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1031-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-01

Product code NPJ

K090763Class IIRestoris Multicompartmental Knee (Mck) SystemMako Surgical Corporation / cleared 2009-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)