Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
FDA Recall Z-1031-2016 · Posted None
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Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeNPJ
Date Initiated2016-01-15
Date Terminated2019-08-06
Product Quantity146
Reason for Recall
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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