CLASS II Device recall · Reported 15 Aug 2018 · FDA Enforcement Report
rHead Standard Extended Stem Collar recalled by Howmedica Osteonics
Howmedica Osteonics is recalling rHead Standard Extended Stem Collar, Size Orthopedic implant for replacement of the, distributed nationwide in the US. The recall was initiated on 24 Oct 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-2703-2018
- FDA event ID
- 79315
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2017
- FDA classified
- 8 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 24 Oct 2017 | Recall initiated by company | |
| 8 Aug 2018 | Classified by FDA | +288 days |
| 15 Aug 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
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Where it was distributed
Distribution US Nationwide.
Questions about this recall
Is rHead Standard Extended Stem Collar, Size Orthopedic implant for replacement of the recalled?
Yes. Howmedica Osteonics recalled rHead Standard Extended Stem Collar, Size Orthopedic implant for replacement of the on 24 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-2703-2018.
Why was it recalled?
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Which lots are affected?
410-0100
Where was it sold?
Distribution US Nationwide.
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 Howmedica Osteonics
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|---|---|---|---|---|---|
| Device | CLASS II | Tri Ts Baseplate Size recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | Nationwide |
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| Device | CLASS II | The Stryker CranialMask Tracker is a single-use device recalled | Howmedica Osteonics | Device Malfunction | Nationwide |
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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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| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |