Reported Mar 23, 2016 · Terminated
Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product…
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 9 consists of all product under HRS
- and same usageItem
- no
47494502601 4.5 BROAD SCP PLT26
- HOL Product UsageTemporary internal fixation devices designed to stabilize fractures during the normal healing process
- Lot codes and dates
- lot no61889853
- Amount recalled
- 0
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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