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
| Model / number | Product as published |
|---|---|
12/14 | Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 |
12/14 | UNIPOLAR FEMORAL HE 781804000 |
12/14 | UNIPOLAR FEMORAL HE 781804100 |
12/14 | UNIPOLAR FEMORAL HE 781804200 |
12/14 | UNIPOLAR FEMORAL HE 781804300 |
12/14 | UNIPOLAR FEMORAL HE 781804400 |
12/14 | UNIPOLAR FEMORAL HE 781804500 |
12/14 | UNIPOLAR FEMORAL HE 781804600 |
12/14 | UNIPOLAR FEMORAL HE 781804700 |
12/14 | UNIPOLAR FEMORAL HE 781804800 |
12/14 | UNIPOLAR FEMORAL HE 781804900 |
12/14 | UNIPOLAR FEMORAL HE 781805000 |
12/14 | UNIPOLAR FEMORAL HE 781805100 |
12/14 | UNIPOLAR FEMORAL HE 781805200 |
12/14 | UNIPOLAR FEMORAL HE 781805300 |
12/14 | UNIPOLAR FEMORAL HE 781805400 |
12/14 | UNIPOLAR FEMORAL HE 781805500 |
12/14 | UNIPOLAR FEMORAL HE 781806300 |
12/14 | UNIPOLAR FEMORAL HE 781809900 |
12/14 | UNIPOLAR FEMORAL HE 781809901 |
- Lot codes and dates
- lot
194 of 194 codes
no.6209710462207231622192246234009162340091N61643437622685526234009262340092N61679532619285126234009362340093N61885911618859126188591361957517621824186221922562240286618859146188591561947602621340356218241262188330622402876234009662340096N61633850616338546213859562240289622408096232261762322617N615458316163016361986626622402916232906862329068N6166453461847124619239396213403062142871621752666218021962199414621994156221199662216689622344916224903262249033623226116233401162322611N62334011N
- lot
- 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.
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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