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Recall Observatory FDA recall evidence

Device product

Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18

Z-1341-2016

March 17, 2016

Class II

Product summary

Firm
Zimmer Manufacturing B.V.
Event
Event 73498
Status
Terminated
Classification
Class II
Quantity
TBD
Official record key
device-enforcement:Z-1341-2016

Official wording

Reason: The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.

Code information: lot 62632101

Distribution pattern: Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.