CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Versys Beaded FC 14X160MM Std Body Ext & Std Neck recalled
Zimmer Biomet is recalling Versys Beaded FC 14X160MM Std Body Ext & Std Neck Prosthesis, Hip, Semi-Constrained, distributed nationwide in the US. The recall was initiated on 29 Nov 2017 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-1024-2018
- FDA event ID
- 78706
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Nov 2017
- FDA classified
- 14 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 29 Nov 2017 | Recall initiated by company | |
| 14 Mar 2018 | Classified by FDA | +105 days |
| 21 Mar 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
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
VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
Questions about this recall
Is Versys Beaded FC 14X160MM Std Body Ext & Std Neck Prosthesis, Hip, Semi-Constrained recalled?
Yes. Zimmer Biomet recalled Versys Beaded FC 14X160MM Std Body Ext & Std Neck Prosthesis, Hip, Semi-Constrained on 29 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-1024-2018.
Why was it recalled?
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Which lots are affected?
Item Number: 00-7843-014-26 Lot Number: 61741806 Item Number: 00-7843-014-06 Lot Numbers: 61886028 61752736 62120676
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
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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| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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