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Devices
Device Recall Simplex P
Model / Serial
Lot Code MBN003, catalog no. 6197-9-010 (10 pk) Lot Code MBN003, catalog no. 6197-9-001 (1 pk) Lot Code MBN004; catalog no. 6197-9-010 (10 pk) Lot code MBN004; catalog no. 6197-9-001 (1 pk) Lot Code MBN003 and MBN004 - powder ''use by'' date 12/2007 Lot Code MBN003 and MBN004 - liquid ''use by'' date 9/2006 Product ''Use By'' Date: September 2006
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide
Product Description
Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
Recall of Device Recall Simplex P
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Manufacturer
Stryker Howmedica Osteonics Corp.
Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
Manufacturer Parent Company (2017)
Stryker
Source
USFDA
Language
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