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U.S. Department of Health and Human Services

Class 2 Device Recall Comfort THandle

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  Class 2 Device Recall Comfort THandle see related information
Date Initiated by Firm December 19, 2007
Date Posted February 13, 2008
Recall Status1 Terminated 3 on October 04, 2010
Recall Number Z-0880-2008
Recall Event ID 46304
510(K)Number K050706  
Product Classification Multi-use Surgical Handle - Product Code GZT
Product Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Harmony 2900-0002-PL, Cadence 1500-0002-PL and Cadence 1500-0008-PL; Distributed by Abbott Spine, Austin, TX 78727.
Code Information Lot Numbers: 13ZD, 14KC, 21NJ, 29XC, 36TP, 38AE, 39NN, 43CC, 43SW, 45KK, and 46WK.
Recalling Firm/
Manufacturer		 Abbott Spine
12708 Riata Vista Cir # B-100
Austin TX 78727-7167
For Additional Information Contact
512-918-2700
Manufacturer Reason
for Recall		 Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.
FDA Determined
Cause 2		 Device Design
Action All medical suppliers with consigned inventory from affected lots were contacted via phone beginning 12/19/07. Consignees notified of potential issue and were asked to inspect their inventory and contact Abbott Spine for return and replacement of the affected handles.
Quantity in Commerce 230 handles.
Distribution Worldwide:Medical suppliers in the following states: AR, AZ, CA, CT, FL, IL, LA, MD, MI, MO, MN, NC, NJ, NM, NV, OH, OK, OR, PA, TX, VA and WI. and country of Spain.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GZT and Original Applicant = SPINAL CONCEPTS, INC.
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