| Class 2 Device Recall Synthes Spine TPAL Spacer System. |  |
Date Initiated by Firm | September 23, 2011 |
Date Posted | November 04, 2011 |
Recall Status1 |
Terminated 3 on December 18, 2014 |
Recall Number | Z-0161-2012 |
Recall Event ID |
60003 |
510(K)Number | K100089 |
Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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Product | Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system.
Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. |
Code Information |
Part number 01.812.001 - T-PAL Instrument and Implant Set |
Recalling Firm/ Manufacturer |
Synthes USA (HQ), Inc. 1302 Wrights Ln E West Chester PA 19380-3417
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For Additional Information Contact | Customer Support 610-719-5000 |
Manufacturer Reason for Recall | LABELING CORRECTION for Medical Device - previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated for use with autograft material. All accounts with record of receiving T-PAL Implant will receive notification of the labeling correction and a copy of the updated brochure. All |
FDA Determined Cause 2 | Error in labeling |
Action | SYNTHES sent an URGENT MEDICAL DEVICE LABELING CORRECTION letter dated September 23, 2011, to all affected customers.
The labeling has been revised. Updated information packets have been sent to all accounts which included the final labeling and communications to accounts and sales force. Customers were instructed to review the updated supplemental labeling provided in the package
Customers were instructed to attach the supplementary technique page to an T-PAL Spacer Brochure that may be in their facility. They can access an electronic version of the Brochure by accesssng Product Literature at the following link:
http://us.synthes.com. The new version can be identified by code J10120 located at the bottom right corner of the back cover.
To confirm receipt and understanding of the information, customers were requested to complete the Verification Section of the letter and return it to Synthes by either of the following methods:
Mail provided postage paid envelope
Fax 610-251-9005
Scan/e-mail to FieldAction@synthes.com
For any questions call 1-800-420-7025 x5403 or contact their Synthes Spine Sales Consultant. |
Quantity in Commerce | N/A - Labeling Correction |
Distribution | Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, HI, KS, KY, LA, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. and Puerto Rico and Washington, D.C; Internationally to Canada and Japan |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = MAX
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