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Terminated

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

FDA Recall Z-1341-2016 · Posted 2016-04-06

Recalling FirmZimmer Manufacturing B.V.
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-03-17
Date Terminated2017-03-14
Product QuantityTBD

Reason for Recall

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.

Firm Action

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

Root Cause

Employee error

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).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113369ZIMMER PERSONA KNEE SYSTEMZimmer, Inc. · 2012-03-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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