Date Initiated by Firm | January 31, 2017 |
Date Posted | February 27, 2017 |
Recall Status1 |
Terminated 3 on December 01, 2017 |
Recall Number | Z-1383-2017 |
Recall Event ID |
76487 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product | PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery.
Part numbers 03.820.350 and 03.820.352.
Used to hold the disc segment open and facilitate discectomy |
Code Information |
Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006 |
Recalling Firm/ Manufacturer |
Synthes (USA) Products LLC 1301 Goshen Pkwy West Chester PA 19380-5986
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For Additional Information Contact | Anne Brisson 800-479-6329 |
Manufacturer Reason for Recall | These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut. The item etched and labeled as 12 mm Strut 03.820.352 lot 5919006 is a 10 mm Strut. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | DePuy Synthes mailed an Urgent Notice to customers affected by the issue on 02/13/2017. The reason for the recall was explained, risks associated with the issue were identified, and actions to be taken were addressed. Customers were asked to complete the enclosed Verification form and mail it back to obtain a Return Authorization Number for the product's return. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant. For questions regarding this recall call 800-479-6329. |
Quantity in Commerce | 2 units |
Distribution | US distribution to TX and LA |
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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