Zimmer Manufacturing B.V.: Medical Device Recall in 2016 - (Recall #: Z-1153-2016)

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 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE LAG SCREW 11MM 225900137 ONE-PIECE LAG SCREW 11MM 225900140 ONE-PIECE LAG SCREW 11MM 225900142 ONE-PIECE LAG SCREW 11MM 225900145 ONE-PIECE LAG SCREW 11MM 225900152 ONE-PIECE LAG SCREW 11MM Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Product Classification:

Class II

Date Initiated: January 11, 2016

Date Posted: March 23, 2016

Recall Number: Z-1153-2016

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: 58320

Code Information:

lot no.: 62133636 61882374 61964347 61987304 62133643 62171285 62298481 61969229 62080367 62292385 61657722 61930479 61930480 61930481 62109268 61136016 61930482 62098917 62098918 61764507 61764508 61764509 61895897 61895905 61895907 61895908

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated