CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report
Product 10consists of all product under product recalled
Zimmer Manufacturing B.V is recalling Product 10consists of all product under product, distributed nationwide in the US. The recall was initiated on 11 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1108-2016
- FDA event ID
- 72900
- Recalling firm
- Zimmer Manufacturing B.V, Mercedita, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2016
- FDA classified
- 12 Mar 2016
- Reported
- 23 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 11 Jan 2016 | Recall initiated by company | |
| 12 Mar 2016 | Classified by FDA | +61 days |
| 23 Mar 2016 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF 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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Product 10consists of all product under product recalled?
Yes. Zimmer Manufacturing B.V recalled Product 10consists of all product under product on 11 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-1108-2016.
Why was it 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.
Which lots are affected?
lot no:61854116 61930079
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zimmer Manufacturing B.V
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|---|---|---|---|---|---|
| Device | CLASS II | Periarticular plating system, cancellous bone screw recalled | Zimmer Manufacturing B.V | Sterility | Nationwide |
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| Device | CLASS II | Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled | Zimmer Manufacturing B.V | Sterility | Nationwide |
| Device | CLASS II | Herbert Cannulated Bone Screw System, Bone Screw Dia recalled | Zimmer Manufacturing B.V | Sterility | Nationwide |
| Device | CLASS II | Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled | Zimmer Manufacturing B.V | Sterility | Nationwide |
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