Recall record at a glance
| Official record | Z-1144-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Manufacturing B.V. |
| Report date | Mar 23, 2016 |
| Recall initiation date | Jan 11, 2016 |
| Quantity | 3190 |
| Location | Mercedita, PR, United States |
Official product description
Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MINI MAGNA-FX CANN SCREW 114204036 MINI MAGNA-FX CANN SCREW 114204040 MINI MAGNA-FX CANN SCREW 114204044 MINI MAGNA-FX CANN SCREW 114204048 MINI MAGNA-FX CANN SCREW 114204055 MINI MAGNA-FX CANN SCREW 114204065 MINI MAGNA-FX CANN SCREW 114204124 MINI MAGNA-FX CANN SCREW 114204126 MINI MAGNA-FX CANN SCREW 114204128 MINI MAGNA-FX CANN SCREW 114204130 MINI MAGNA-FX CANN SCREW 114204132 MINI MAGNA-FX CANN SCREW 114204134 MINI MAGNA-FX CANN SCREW 114204136 MINI MAGNA-FX CANN SCREW 114204138 MINI MAGNA-FX CANN SCREW 114204140 MINI MAGNA-FX CANN SCREW 114204142 MINI MAGNA-FX CANN SCREW 114204144 MINI MAGNA-FX CANN SCREW 114204146 MINI MAGNA-FX CANN SCREW 114204148 MINI MAGNA-FX CANN SCREW 114204150 MINI MAGNA-FX CANN SCREW 114204155 MINI MAGNA-FX CANN SCREW 114204160 MINI MAGNA-FX CANN SCREW 114204165 MINI MAGNA-FX CANN SCREW 114204170 MINI MAGNA-FX CANN SCREW 114205012 MINI MAGNA-FX CANN SCREW 114205016 MINI MAGNA-FX CANN SCREW 114205020 MINI MAGNA-FX CANN SCREW 114205024 MINI MAGNA-FX CANN SCREW 114205028 MINI MAGNA-FX CANN SCREW 114205032 MINI MAGNA-FX CANN SCREW 114205036 MINI MAGNA-FX CANN SCREW 114205040 MINI MAGNA-FX CANN SCREW 114205044 MINI MAGNA-FX CANN SCREW 114205048 MINI MAGNA-FX CANN SCREW 114205055 MINI MAGNA-FX CANN SCREW 114205065 MINI MAGNA-FX CANN SCREW 114205124 MINI MAGNA-FX CANN SCREW 114205126 MINI MAGNA-FX CANN SCREW 114205128 MINI MAGNA-FX CANN SCREW 114205130 MINI MAGNA-FX CANN SCREW 114205132 MINI MAGNA-FX CANN SCREW 114205134 MINI MAGNA-FX CANN SCREW 114205136 MINI MAGNA-FX CANN SCREW 114205138 MINI MAGNA-FX CANN SCREW 114205140 MINI MAGNA-FX CANN SCREW 114205142 MINI MAGNA-FX CANN SCREW 114205144 MINI MAGNA-FX CANN SCREW 114205146 MINI MAGNA-FX CANN SCREW 114205148 MINI MAGNA-FX CANN SCREW 114205150 MINI MAGNA-FX CANN SCREW 114205155 MINI MAGNA-FX CANN SCREW 114205160 MINI MAGNA-FX CANN SCREW 114205165 MINI MAGNA-FX CANN SCREW 114205170 MINI MAGNA-FX CANN SCREW Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Why the product 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.
Distribution information
US Nationwide Distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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