Zimmer Manufacturing B.V.: Medical Device Recall in 2016 - (Recall #: Z-1136-2016)

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 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG 225303555 INTERLOCKING IM SCREW LG 225303755 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225302742 INTERLOCKING IM SCREW MED 225303242 INTERLOCKING IM SCREW MED 225307042 INTERLOCKING IM SCREW MED 225302737 INTERLOCKING IM SCREW SML 225303237 INTERLOCKING IM SCREW SML Product 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-1136-2016

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: 4752

Code Information:

lot no.: 61793328 62253390 61641813 62194666 61993625 62262085 62313056 62313056N 62021140 62312364 62312364N 61817404 61809837 61851878 61987145 62165485 62244841 62244854 61763549 61826386 61851889 61968098 62114111 62114112 62172486 61804389 61841502 61872521 61962448 61983689 62137121 62244852 61665045 61841504 62031683 62137150 62244853 61809838 62306323 62306323N 61830462 61809839 62189554 61804722 61830471 62165499 62165501 62189558 61809843

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated