Zimmer Manufacturing B.V.: Medical Device Recall in 2016 - (Recall #: Z-1133-2016)

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 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty

Product Classification:

Class II

Date Initiated: January 11, 2016

Date Posted: March 23, 2016

Recall Number: Z-1133-2016

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: 49

Code Information:

lot no.: 62207450

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated