Reported Mar 23, 2016 · Terminated

Product 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG…

Zimmer Manufacturing B.V.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Manufacturing B.V. · Turpeaux Industrial Park Rd 1 km 123.4 · Mercedita, PR · 00715

Is this the product you have?

  • Product 38 consists
  • of all product under product codeHSB
  • and same usageItem
  • no225303255 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 UsageAn 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
Lot codes and dates
  • 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
Amount recalled
4752

This recall covers 72 products

The agency filed one notice per product. You are reading one of them; the other 71 are below.

59 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 13, 2017 · Data as of Sep 19, 5:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.