Zimmer Manufacturing B.V.: Medical Device Recall in 2016 - (Recall #: Z-1146-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 11, 2016

Date Posted: March 23, 2016

Recall Number: Z-1146-2016

Event ID: 72900

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.

Status: Terminated

Product Quantity: 0

Code Information:

lot no.: 61873094 61895696 61905916 61905918 61905920 61919766 61919767 61919768 61956249 61956250 61981202 61981204 61999375 62027331 62060784 62074467 62074469 62096750 62096751 62133740 62164984 62168517 62171693 62171694 62171696 62174936 62205101 62213332 62213333 62220943 62345691 62345692 62345693 62345694 62352447 62352450

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated