Reported Mar 23, 2016 · Terminated

Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA…

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 60 consists
  • of all product under product codeHSB
  • and same usageItem
  • no225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 RECON SCREW LG 5.5MM DIA 225210055 RECON SCREW LG 5.5MM DIA 225210555 RECON SCREW LG 5.5MM DIA 225211555 RECON SCREW LG 5.5MM DIA 225212055 RECON SCREW LG 5.5MM DIA 225213055 RECON SCREW LG 5.5MM
  • DIA 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.:

    61 of 61 codes

    • 61893774
    • 61968082
    • 62153448
    • 62296426
    • 62296426N
    • 61983672
    • 62153447
    • 61827280
    • 61920741
    • 61964034
    • 62108027
    • 62108029
    • 62153449
    • 61835479
    • 61878730
    • 61878732
    • 61940068
    • 61940069
    • 62121105
    • 62121106
    • 62121107
    • 62121108
    • 61621138
    • 61878733
    • 61929350
    • 61940070
    • 61940071
    • 62086349
    • 62086350
    • 62086351
    • 62086353
    • 62086355
    • 62086356
    • 62153450
    • 61763506
    • 61878734
    • 61878735
    • 61940072
    • 62121116
    • 62121117
    • 62121118
    • 62121119
    • 61878736
    • 61929351
    • 61940076
    • 62121110
    • 62121111
    • 62121112
    • 62121113
    • 62103433
    • 61597004
    • 61597004N
    • 61906259
    • 61895931
    • 61895932
    • 61895933
    • 61895935
    • 61912972
    • 61912975
    • 61912976
Amount recalled
1394

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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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.