Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two
FDA device recall Z-1238-2013 · posted 2013-05-03 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.
- Action taken
- Synthes sent an Urgent Notice: Medical Device Recall letter dated February 22, 2013, to all affected consignees. The letter requested consignees examine their inventory, remove them from use and return them to Synthes. Customers were asked to complete the attached Verification Section at the end of the letter indicating whether or not they have any of the affected product. For questions customers were instructed to call 610-719-5450 or email FieldAction@synthes.com. For questions regarding this recall call 610-719-5000.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWI
- Quantity affected
- 417
- Distribution
- Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI.
- Date initiated
- 2013-02-22
- Date posted
- 2013-05-03
- Date terminated
- 2015-08-31
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES RADIAL HEAD PROSTHESIS SYSTEM (K112030) | Synthes USA, LLC | 2012-06-19 |