Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device
FDA device recall Z-2184-2014 · posted 2014-08-12 · Terminated
Recall details
- Recalling firm
- Codman & Shurtleff, Inc.
- Reason for recall
- To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Action taken
- Codman Neuro sent an Urgent Medical Device Safety Notification dated July 17, 2014, to clinicians who use the device. The notification clarifies the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). Consignees are also asked to complete the enclosed Acknowledgement Form and fax the completed form to 1-888-239-1305. For questions or concerns regarding this notification, consignees are instructed to contact their local Codman Neuro Representative or Scientific and Medical Affairs at SciMedAffairs@its.jnj.com or (866) 685-7325. For questions regarding this recall call 508-828-2726.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 9,498 devices total
- Distribution
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, W
- Date initiated
- 2014-07-03
- Date posted
- 2014-08-12
- Date terminated
- 2017-01-30
- Location
- Raynham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM (K113526) | Medos International SARL | 2012-02-16 |
| CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM (K112156) | Medos International SARL | 2011-10-17 |