Reported Mar 23, 2016 · Terminated

Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE…

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?

21 of 21 products

Products covered by this recall
Model / numberProduct as published
12/14Product 3 consists of all products under product code JDI, and same usage: Item no:781803800
12/14UNIPOLAR FEMORAL HE 781804000
12/14UNIPOLAR FEMORAL HE 781804100
12/14UNIPOLAR FEMORAL HE 781804200
12/14UNIPOLAR FEMORAL HE 781804300
12/14UNIPOLAR FEMORAL HE 781804400
12/14UNIPOLAR FEMORAL HE 781804500
12/14UNIPOLAR FEMORAL HE 781804600
12/14UNIPOLAR FEMORAL HE 781804700
12/14UNIPOLAR FEMORAL HE 781804800
12/14UNIPOLAR FEMORAL HE 781804900
12/14UNIPOLAR FEMORAL HE 781805000
12/14UNIPOLAR FEMORAL HE 781805100
12/14UNIPOLAR FEMORAL HE 781805200
12/14UNIPOLAR FEMORAL HE 781805300
12/14UNIPOLAR FEMORAL HE 781805400
12/14UNIPOLAR FEMORAL HE 781805500
12/14UNIPOLAR FEMORAL HE 781806300
12/14UNIPOLAR FEMORAL HE 781809900
12/14UNIPOLAR FEMORAL HE 781809901
Lot codes and dates
  • lot

    194 of 194 codes

    • no.62097104
    • 62207231
    • 62219224
    • 62340091
    • 62340091N
    • 61643437
    • 62268552
    • 62340092
    • 62340092N
    • 61679532
    • 61928512
    • 62340093
    • 62340093N
    • 61885911
    • 61885912
    • 61885913
    • 61957517
    • 62182418
    • 62219225
    • 62240286
    • 61885914
    • 61885915
    • 61947602
    • 62134035
    • 62182412
    • 62188330
    • 62240287
    • 62340096
    • 62340096N
    • 61633850
    • 61633854
    • 62138595
    • 62240289
    • 62240809
    • 62322617
    • 62322617N
    • 61545831
    • 61630163
    • 61986626
    • 62240291
    • 62329068
    • 62329068N
    • 61664534
    • 61847124
    • 61923939
    • 62134030
    • 62142871
    • 62175266
    • 62180219
    • 62199414
    • 62199415
    • 62211996
    • 62216689
    • 62234491
    • 62249032
    • 62249033
    • 62322611
    • 62334011
    • 62322611N
    • 62334011N
Amount recalled
2,239

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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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, 6:01 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.