Recall record at a glance
| Official record | Z-1130-2016 |
|---|---|
| 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 | 4018 |
| Location | Mercedita, PR, United States |
Official product description
Product 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM 47115401800 HERBERT BONE SCREW, 3.0MM 47115402000 HERBERT BONE SCREW, 3.0MM 47115402200 HERBERT BONE SCREW, 3.0MM 47115402400 HERBERT BONE SCREW, 3.0MM 47115402600 HERBERT BONE SCREW, 3.0MM 47115402800 HERBERT BONE SCREW, 3.0MM 47115403000 HERBERT BONE SCREW, 3.0MM 47115502505 HERBERT CANNULATED BONE S 47115503005 HERBERT CANNULATED BONE S 47115503505 HERBERT CANNULATED BONE S 47115504005 HERBERT CANNULATED BONE S 47115504007 HERBERT CANNULATED BONE S 47115504505 HERBERT CANNULATED BONE S 47115504507 HERBERT CANNULATED BONE S 47115505005 HERBERT CANNULATED BONE S 47115505007 HERBERT CANNULATED BONE S 47115505505 HERBERT CANNULATED BONE S 47115505507 HERBERT CANNULATED BONE S 47115506005 HERBERT CANNULATED BONE S 47115506007 HERBERT CANNULATED BONE S 47115506505 HERBERT CANNULATED BONE S 47115506507 HERBERT CANNULATED BONE S 47115507005 HERBERT CANNULATED BONE S 47115507007 HERBERT CANNULATED BONE S 47115507505 HERBERT CANNULATED BONE S 47115507507 HERBERT CANNULATED BONE S 47115508005 HERBERT CANNULATED BONE S 47115508007 HERBERT CANNULATED BONE S 47115508505 HERBERT CANNULATED BONE S 47115508507 HERBERT CANNULATED BONE S 47115509005 HERBERT CANNULATED BONE S 47115509007 HERBERT CANNULATED BONE S 47115509505 HERBERT CANNULATED BONE S 47115509507 HERBERT CANNULATED BONE S 47115510005 HERBERT CANNULATED BONE S 47115510007 HERBERT CANNULATED BONE S 115001000 HERBERT MINI BONE SCREW 2 115001200 HERBERT MINI BONE SCREW 2 115001400 HERBERT MINI BONE SCREW 2 115001600 HERBERT MINI BONE SCREW 2 115001800 HERBERT MINI BONE SCREW 2 115002000 HERBERT MINI BONE SCREW 2 115002200 HERBERT MINI BONE SCREW 2 115002400 HERBERT MINI BONE SCREW 2 115201200 HERBERT/WHIPPLE CANN BONE 115201400 HERBERT/WHIPPLE CANN BONE 115201600 HERBERT/WHIPPLE CANN BONE 115201800 HERBERT/WHIPPLE CANN BONE 115202000 HERBERT/WHIPPLE CANN BONE 115202200 HERBERT/WHIPPLE CANN BONE 115202400 HERBERT/WHIPPLE CANN BONE 115202600 HERBERT/WHIPPLE CANN BONE 115202800 HERBERT/WHIPPLE CANN BONE 115203000 HERBERT/WHIPPLE CANN BONE 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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