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U.S. Department of Health and Human Services

Class 2 Device Recall Normed General Instruments

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 Class 2 Device Recall Normed General Instrumentssee related information
Date Initiated by FirmMay 11, 2017
Date PostedMay 15, 2017
Recall Status1 Terminated 3 on November 03, 2017
Recall NumberZ-2111-2017
Recall Event ID 77262
Product Classification Burr, orthopedic - Product Code HTT
ProductNormed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
Code Information Lots: 13065 13569 13571
FEI Number 3005233524
Recalling Firm/
Manufacturer		 Zimmer Gmbh
Sulzer Allee 8
Winterthur Switzerland
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionZimmer Biomet sent an URGENT MEDICAL DEVICE RECALL REMOVAL letter dated  May 11 2017. Lot Specific notifications were sent to the affected consignee via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions were instructed to call Technical Services at 1-574-371-3071.
Quantity in Commerce138 (OUS 297)
DistributionSingle US consignee CO.
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.
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