CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report
HHXL (OVO) 15.6x32mm Taper Post Fixation Component recalled
Arthrosurface is recalling HHXL (OVO) 15.6x32mm Taper Post Fixation Component, distributed nationwide in the US. The recall was initiated on 24 Nov 2014 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-1114-2015
- FDA event ID
- 69723
- Recalling firm
- Arthrosurface, Franklin, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Nov 2014
- FDA classified
- 12 Feb 2015
- Reported
- 18 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 24 Nov 2014 | Recall initiated by company | |
| 12 Feb 2015 | Classified by FDA | +80 days |
| 18 Feb 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Product as listed by the FDA
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Where it was distributed
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Questions about this recall
Why was it recalled?
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Which lots are affected?
Catalog Number: 8156-0032, Part Number: 156-0032
Where was it sold?
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 69723This product is part of a recall event; the main page for the event is 25& 12.5x32mm Taper Post Fixation Component recalled by Arthrosurface.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 25& 12.5x32mm Taper Post Fixation Component recalled by Arthrosurface | Arthrosurface | Other | Nationwide | |
| CLASS II | 13.5x32mm Taper Post Fixation Component recalled by Arthrosurface | Arthrosurface | Other | Nationwide | |
| CLASS II | Athrosurface 13.75x31mm Taper Post Fixation Component recalled | Arthrosurface | Other | Nationwide | |
| CLASS II | 25& 10.5x28mm Taper Post Fixation Component recalled by Arthrosurface | Arthrosurface | Other | Nationwide |
More recalls from Arthrosurface
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Total Toe Instrument Kit, Labeled in part recalled by Arthrosurface | Arthrosurface | Sterility | CA, PA, WV |
| Device | CLASS II | 25& 10.5x28mm Taper Post Fixation Component recalled by Arthrosurface | Arthrosurface | Other | Nationwide |
| Device | CLASS II | Athrosurface 13.75x31mm Taper Post Fixation Component recalled | Arthrosurface | Other | Nationwide |
| Device | CLASS II | 13.5x32mm Taper Post Fixation Component recalled by Arthrosurface | Arthrosurface | Other | Nationwide |
| Device | CLASS II | 25& 12.5x32mm Taper Post Fixation Component recalled by Arthrosurface | Arthrosurface | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,118| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Hip Scope Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | Grafton" DBM and Grafton Plus" DBM contain demineralized recalled | Medtronic Sofamor Danek USA | Other Bacterial Contamination | Nationwide |