Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
This recall has been terminated (originally issued January 15, 2016).
- Company
- Mako Surgical Corporation
- Recall Initiated
- January 15, 2016
- Terminated
- August 6, 2019
- Recall Number
- Z-1031-2016
- Quantity
- 146
- Firm Location
- Plantation, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
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.
Lot / Code Info
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.
Root Cause
Unknown/Undetermined by firm
Action Taken
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 StrykerOrtho5317@Stericycle.com 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.