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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes XRL Medium TrialCentral Body

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 Class 2 Recall
Synthes XRL Medium TrialCentral Body
see related information
Date Posted June 02, 2014
Recall Status1 Open
Recall Number Z-1681-2014
Recall Event ID 68006
Premarket Notification
510(K) Number
K103320 
Product Classification Spinal Vertebral Body Replacement Device - Product Code MQP
Product Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).
Code Information Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.
Recalling Firm/
Manufacturer
Synthes, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall
Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Synthes sent an Urgent Notice: Medical Device Recall letter dated April 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action Required: Synthes has record that your facility has the product(s) subject to this recall. Synthes asks that you review your inventory and immediately remove the affected lots from stock. If you DO have any of the identified devices, please take the following steps: Contact your local Synthes Spine Sales Consultant to return any inventory located within your facility. Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided. Return the Verification Form (page 4 of this letter) to: Fax: 877-270-9246 or Scan/email: Synthes3041@stericycle.com If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. Return the documents to Synthes by: Fax: 877-270-9246 or Scan/email: Synthes3041@stericycle.com Note: If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification. If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant.
Quantity in Commerce 3
Distribution US Distribution including the states of FL, NJ and MN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQP and Original Applicant = SYNTHES SPINE CO.LP
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