SMARTPREP2 Bmac System, Smartprep Platelet Concentration System

• 2 recalls, same reason

  • Terminated Z-0104-2018 FDA Class II ·initiated 20 Oct 2017
  • Terminated Z-0103-2018 FDA Class II ·initiated 20 Oct 2017

  The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. The expiration noted was not beyond initiation date of the recall. Since the product is noted as sterile, the clearance for K103340, K052925 and K991430 raises question if product was cleared with a sterility claim. Further post-market follow-up will be required to assess the safety risk of the product.

510(k) Number

K103340 ↗

FDA Product Code

JQC

Device Class

Class I

Regulation

21 CFR Part 862.2050

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Smartprep Centrifuge System

  Class I

  FDA 510(k) K991430 Active Cleared 28 May 1999

• Smartjet Bone Graft Liquid Applicator (Spray Tip), Model Sk/S, Smartjet Bone Graft Liquid Applicator (Dual Lumen Cannula

  Class II

  FDA 510(k) K011032 Active Cleared 3 Jul 2001

• Smartjet Grafting Liquid Applicator, Models Sk/S & Lk/2

  Class II

  FDA 510(k) K020252 Active Cleared 5 Apr 2002

• SMARTPREP2 Centrifuge System

  Class I

  FDA 510(k) K052925 Active Cleared 4 Jan 2006

• Adiprep Adipose Transfer System

  Class II

  FDA 510(k) K121005 Active Cleared 21 Sep 2012

• SmartCell Processing System

  Class II

  FDA 510(k) K983022 Active Cleared 2 Apr 1999

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