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U.S. Department of Health and Human Services

Class 2 Device Recall PRODISC

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 Class 2 Device Recall PRODISCsee related information
Date Initiated by FirmJanuary 31, 2017
Date PostedFebruary 27, 2017
Recall Status1 Terminated 3 on December 01, 2017
Recall NumberZ-1383-2017
Recall Event ID 76487
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductPRODISC 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
For Additional Information ContactAnne 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
ActionDePuy 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 Commerce2 units
DistributionUS distribution to TX and LA
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.
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