Recall Z-1383-2016
Synthes (USA) Products LLC · initiated December 8, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Codes / lots: SYNTHECEL Dura Repair 2.5 cm x 2.5 cm (1x1), part numbers: SC.400.006.01S, Lot Numbers: 7840311, 7855336, 7860563, 7909569, 7922340, 7932410, 7984104
Reason for recall
It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.
FDA-determined cause: Labeling False and Misleading
Action taken
Siemens mailed out an Urgent: Field Safety Notification letter informing customers to review the replacement package insert (GP2715-C) and discard the outdated package insert (GP2715-B) and outdated promotional materials. Customers were asked to complete the verification section (page 3 of the recall notification) and send a copy of the completed Verification Section by Fax (888)912-7351 or Scan/Email to Synthes5875@stericycle.com
Details
- Recall number
- Z-1383-2016
- Initiated
- December 8, 2015
- Terminated
- August 26, 2016
- Product code
- GXQ – Dura Substitute
- Quantity
- 212 units
- Distribution
- Nationwide: NY, PA, AL, WI, FL, MO, TN, OH, MI, MN, CO, CA, NV, AZ, LA, OR, TX, IA, IN, MS, IL, AR, WV, HI, VA, MD, WA, OK, MA, KY, NJ, CT, No foreign accounts.
- Recalling firm
- Synthes (USA) Products LLC, West Chester, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1384-2016 Class II | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post… | 12/08/2015Terminated |
| Z-1385-2016 Class II | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post… | 12/08/2015Terminated |
| Z-1386-2016 Class II | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post… | 12/08/2015Terminated |
| Z-1387-2016 Class II | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post… | 12/08/2015Terminated |