Reported Mar 23, 2016 · Terminated

Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM…

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 70 consists
  • of all product under product codeJDI
  • and same usageItem
  • no785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE FEM STEM 785701200 VERSYS HERITAGE FEM STEM 785701300 VERSYS HERITAGE FEM STEM 785701320 VERSYS HERITAGE FEM STEM 785701400 VERSYS HERITAGE FEM STEM 785701420 VERSYS HERITAGE FEM STEM 785701500 VERSYS HERITAGE FEM STEM 785701520 VERSYS HERITAGE FEM STEM 785701600 VERSYS HERITAGE FEM STEM 785701700 VERSYS HERITAGE FEM STEM For use in total or hemi hip arthroplasty
Lot codes and dates
  • lot no.:

    84 of 84 codes

    • 61661156
    • 61966578
    • 62225735
    • 61873650
    • 61962858
    • 62137227
    • 62137228
    • 62240762
    • 62340060
    • 62340060N
    • 61820823
    • 61881193
    • 61957419
    • 61962855
    • 62172047
    • 62175238
    • 62234460
    • 62262787
    • 62291935
    • 62298291
    • 62298292
    • 62310454
    • 62314656
    • 62340058
    • 62298291N
    • 62310454N
    • 62314656N
    • 62340058N
    • 61878467
    • 61881194
    • 61883397
    • 61886939
    • 61899754
    • 61968010
    • 62221008
    • 62284504
    • 62285272
    • 62291937
    • 62291937N
    • 61822322
    • 62032180
    • 62260128
    • 62304808
    • 62340062
    • 62358896
    • 62304808N
    • 62340062N
    • 61813932
    • 61820819
    • 61980168
    • 62205493
    • 62240263
    • 62240771
    • 62240772
    • 62240773
    • 62240774
    • 62282932
    • 62291138
    • 62291938
    • 62296576
Amount recalled
360

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.

Free recall alerts

Get alerted about new Zimmer Manufacturing B.V. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 5:21 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.