Skip to content
Recall Observatory FDA recall evidence

Device product

ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

Z-1314-2021

February 22, 2021

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 87433
Status
Terminated
Classification
Class II
Quantity
102 units total (Domestic: 6 units, Foreign: 86 units)
Official record key
device-enforcement:Z-1314-2021

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#: 9558300, Product Code: 150670003, GTIN 10603295492054 Lot#: 9555958, Product Code: 150670004, GTIN 10603295492061 Lot#: 9554006, Product Code: 150670005, GTIN 10603295492078 Lot#: 9556397, Product Code: 150670005, GTIN 10603295492078 Lot#: 9558618, Product Code: 150670006, GTIN 10603295492085 Lot#: 9557992, Product Code: 150670007, GTIN 10603295492092 Lot#: 9558238, Product Code: 150670008, GTIN 10603295492108 Lot#: 9558239, Product Code: 150670008, GTIN 10603295492108 Lot#: 9555613, Product Code: 150670009, GTIN 10603295492115

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.