Z-1644-2018Class II

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements

Name: Z-1644-2018 RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements
Creator: Mako Surgical Corporation
Published: 2017-12-01
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2017-12-01 / Terminated / root cause: labeling and UDI

FDA source

Mako Surgical Corporation began a recall of RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements on 2017-12-01. FDA classified it as Class II and gives the reason as "Incorrect product and/or label. Sizing is labeled incorrectly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1644-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-01
Posted: 2018-05-04
Terminated: 2020-12-14
Recalling firm: Mako Surgical Corp.
Product: RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Incorrect product and/or label. Sizing is labeled incorrectly.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: An URGENT MEDICAL DEVICE RECALL was sent on December 05, 2017 Product Field Action #: 1658081 Description: MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7 Item No.: 180612; Lot Number: 26080317-01180617; and Lot Number: 26150217-01 Dear Customer, Stryker has initiated an urgent, voluntary, lot-specific recall for the MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLA TE-RM/LL-SZ 7 referenced above. The intent of this letter is to inform you of the product recall that was initiated on December 01, 2017 by Stryker, and to list known hazards potentially associated with the use of the above referenced products and list the risk mitigation factors. Stryker has discovered that the packaging of certain sizes and lots of the above-referenced product may contain the incorrect product and/or label. Two reports were received with the product/label discrepancy. In one report, the labeling of the implant box outer label stated Size 2 RM/LL, and the labeling of the implant sticker (Patient label) located inside the outer box stated Size 7 RM/LL. The correct implant Size 2RM/LL was inside the box. The patient label was incorrect in this report. The second report described that a size 2 implant was in a box labeled as a size 7 implant. Potential Hazards Technical and medical assessments are currently underway to determine any potential hazards associated with the use of the product. Additional communication will be forwarded upon completion of the internal investigation on this issue. Risk Mitigation The difference in Size 2 RM/LL implant and Size 7 RM/LL implant is easily identified by the end user and would not likely be implanted as the discrepancy would be obvious. Actions Needed 1. Please inform users of this Urgent Product Recall and forward this notice to all individuals who need to be aware within your organization 2. Hospitals/Branches/Agencies: Complete and sign the enclosed Recall Notification Business Reply Form and
Quantity in commerce: 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
Product codes and lots: Size 2 Item # 180612 Lot # 26080317-01 and Size 7 Item # 180617 Lot # 26150217-01.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1644-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1644-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code OLO

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)