CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report
Sidus" Head (Not recalled by Zimmer
Zimmer is recalling Sidus" Head (Not, distributed nationwide in the US. The recall was initiated on 30 Aug 2013 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-0079-2014
- FDA event ID
- 65799
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Aug 2013
- FDA classified
- 25 Oct 2013
- Reported
- 6 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 30 Aug 2013 | Recall initiated by company | |
| 25 Oct 2013 | Classified by FDA | +56 days |
| 6 Nov 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Sidus" Head (Not distributed in the United States)
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
Questions about this recall
Is Sidus" Head (Not recalled?
Yes. Zimmer recalled Sidus" Head (Not on 30 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-0079-2014.
Why was it recalled?
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Which lots are affected?
Part Number Range: 01.04555.380/525
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
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.
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