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U.S. Department of Health and Human Services

Class 2 Device Recall SpeedLink 5.5 Transverse Connector

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  Class 2 Device Recall SpeedLink 5.5 Transverse Connector see related information
Date Initiated by Firm January 01, 2009
Date Posted October 08, 2010
Recall Status1 Terminated 3 on January 05, 2011
Recall Number Z-0027-2011
Recall Event ID 54527
510(K)Number K002082  
Product Classification Spinal Interlaminal Fixation Appliance - Product Code KWP
Product SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Code Information 10FU, 10FY, 10UG, 10UK, 10ZC, 10ZK, 10ZM, 11GE, 11ZU, 12LT, 13CJ, 13WX, 14ME, 15EC, 15XV, 16RB, 17YK, 18JY, 19KT, 20PY, 22JA, 27LH, 28NF, 29RA, 30HL, 30NP, 32YS, 34EP, 34WB, 35HZ, 35SY, 36FD, 36NT, 37RF, 37XW, 38PF, 38YE, 39JF, 39RG, 40EF, 40TS, 41HA, 42EB, 43GN, 43TQ, 44CL, 44KN, 45BD, 45JZ, 45NG, 45WS, 55QJ, 55QK, 55QL, 56FE.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
574-267-6131
Manufacturer Reason
for Recall		 The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.
FDA Determined
Cause 2		 Other
Action The firm provided a revised surgical technique document to the Zimmer spine sales force in January, 2009. The firm will provide an Urgent Medical Device Correction notification to speedlink users through the sales force.
Quantity in Commerce 23,205 Units for ALL PRODUCTS IN THIS RECALL
Distribution The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution.
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 = KWP and Original Applicant = SPINAL CONCEPTS, INC.
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