Reported Mar 23, 2016 · Terminated
Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14MM…
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 18 consists
- of all product under product codeHWC
- and same usageItem
- no47248001441 CANC SCR 4.0MM X 14MM FUL 47248001641 CANC SCR 4.0MM X 16MM FUL 47248001840 CANC SCR 4.0MM X 18MM 47248001841 CANC SCR 4.0MM X 18MM FUL 47248002041 CANC SCR 4.0MM X 20MM FUL 47248002441 CANC SCR 4.0MM X 24MM FUL 47248003641 CANC SCR 4.0MM
- X 36MM FUL Product UsageA 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
- Lot codes and dates
- lot no.:
620507366223045662261576619767456212776362230457622616276226165961955473
- lot no.:
- Amount recalled
- 83
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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