Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0530-05

Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers)

Interpore Cross International Inc / initiated 2005-01-14 / Terminated / root cause: labeling and UDI

Interpore Cross International Inc began a recall of Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers) on . The reason FDA records is "Mislabeled". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0530-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Interpore Cross International Inc
Product
Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers)
Product code
MQP Spinal Vertebral Body Replacement Device
Reason for recall
Mislabeled.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Firm sent recall letters on 1/18/2005 requesting return of product. A response form was enclosed.
Quantity in commerce
63
Distribution
TN, MT, MI, CA, IN, PA, NJ, TX, KY, LA, CO.
Product codes and lots
NEXUS Product List Of Catalog Numbers & Lot Numbers     Catalog Number Lot Number/s 1000-3000 300510  303512A  302909A  303012  302812A  302912  302109  303009 1000-3001 326408A  304009  304509 1000-3003 301210  305809A  305509  304709A  305109  324508 1000-3004 304011A  310110  303911A 1000-3005 304211A  312410  301112  304311 1000-3010 302407  300404 1000-3011 313207 1000-3013 307404  312107  312307A 1000-3015 306911A  309505  305605  305905  307111