Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
FDA device recall Z-2292-2013 · posted 2013-09-27 · Terminated
Recall details
- Recalling firm
- Ebi, Llc
- Reason for recall
- Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
- Action taken
- Biomet LLC sent "Urgent Medical Device Recall" letters/fax back response forms on Tuesday April 9, 2013 via Fed Ex to all distributors. The notification identified the problem, product involved, and risk factors. In addition, the notification provides instructions to the representatives on how to return the product to EBI, LLC. Surgeons that have implanted the product were contacted on April 12, 2013.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 1730 units
- Distribution
- Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.
- Date initiated
- 2013-04-09
- Date posted
- 2013-09-27
- Date terminated
- 2014-06-17
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM (K093629) | Biomet Spine | 2010-03-09 |