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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 THandlesee related information
Date Initiated by FirmDecember 19, 2007
Date PostedFebruary 13, 2008
Recall Status1 Terminated 3 on October 04, 2010
Recall NumberZ-0880-2008
Recall Event ID 46304
510(K)NumberK050706 
Product Classification Multi-use Surgical Handle - Product Code GZT
ProductComfort 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.
FEI Number 3000718496
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
ActionAll 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 Commerce230 handles.
DistributionWorldwide: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 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 = GZT
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