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Persona The Personalized Knee System Articular Surface… recallZ-1341-2016 · Zimmer Manufacturing B.V. · initiated Mar 17, 2016

Class II Terminated All recalls posted in April 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Manufacturing B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Employee error

What the company is doing

Distributors, Sales Representatives, Operation Managers, and Hospital Risk Managers will be provided with an "Urgent Medical Device Recall-Lot Specific" letter.

Recall details

Recall number
Z-1341-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 17, 2016
Posted by the FDA
Apr 6, 2016
Recalling firm
Zimmer Manufacturing B.V.
Quantity
TBD
Product code
JWH
FDA submissions
K113369
Distribution
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).

Product description

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

Code information (models, lots, serial numbers)

lot 62632101

Other devices under the same FDA submission

249 devices cleared under K113369 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 73498).

Sources and updates

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