Recall Z-1146-2016— Zimmer Manufacturing B.V.

Name: FDA recall Z-1146-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-11

Class II · Terminated

Class II FDA medical device recall by Zimmer Manufacturing B.V., initiated 2016-01-11, terminated 2017-04-13. It names one FDA 510(k) clearance: K960279. Product: Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total knee arthroplasty. Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile..

Recalling firm: Zimmer Manufacturing B.V.
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Terminated: 2017-04-13
Firm location: Mercedita, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K960279 — NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACESZimmer, Inc.·cleared 1996-04-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total knee arthroplasty

Reason for recall

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Data sourced from openFDA. This site is unofficial and independent of the FDA.