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Recall Observatory FDA recall evidence

Device product

The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

Z-1315-2021

February 22, 2021

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 87433
Status
Terminated
Classification
Class II
Quantity
102 units total (Domestic: 0 units, Foreign: 162 units)
Official record key
device-enforcement:Z-1315-2021

Official wording

Reason: Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

Code information: Lot#: 9543538, Product Code: 129433130, GTIN 10603295025788 Lot#: 9553989, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554547, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554548, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554551, Product Code: 129433130, GTIN 10603295025788 Lot#: 9548774, Product Code: 129433140, GTIN 10603295025795 Lot#: 9548777, Product Code: 129433140, GTIN 10603295025795 Lot#: 9554569, Product Code: 129433140, GTIN 10603295025795

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.