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U.S. Department of Health and Human Services

Class 2 Device Recall Rotating Cutter

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 Class 2 Device Recall Rotating Cuttersee related information
Date Initiated by FirmFebruary 06, 2012
Date PostedFebruary 15, 2012
Recall Status1 Terminated 3 on June 11, 2012
Recall NumberZ-1037-2012
Recall Event ID 61117
510(K)NumberK103111 
Product Classification surgical instrument - Product Code max
ProductOrthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium.
Code Information Catalog Number 89-0452 (8mm Rotating Cutter) - Production Identification (Lot) Numbers 33056-ND25 and 33056-NE19; Catalog Number 89-0454 (10mm Rotating Cutter) - Production Identification (Lot) Numbers 33056-ND26 and 33056-NF02; Catalog Number 89-0030 (FORZA Discectomy Case);   UPDATED INFORMATION AS OF 04/12/2012: The firm has revised to amend the affected lot information; lot number 34346-NH30 (PN 89-0545) has been added. At the time of recall initiation 3 units from lot 34346-NH30 were in distribution; all 3 units have since been returned to Orthofix. Recall notice stated all lots are to be returned so all other information remains unchanged. 
Recalling Firm/
Manufacturer		 Orthofix, Inc.
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information ContactDiana Easton
214-937-2509
Manufacturer Reason
for Recall		The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.
FDA Determined
Cause 2		Device Design
ActionOrthofix mailed recall letters to the distributors on 02/06/2012. Orthofix does not sell or consign these instruments to hospitals.
Quantity in Commerce52
DistributionNationwide and Puerto Rico
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = max
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