Reported Feb 13, 2019 · Terminated
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Ascension Orthopedics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ascension Orthopedics, Inc · 8700 Cameron Rd Ste 100 · Austin, TX · 78754-3947
Is this the product you have?
- Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
- Lot codes and dates
- 170691
Where it was sold
Why it was recalled
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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