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U.S. Department of Health and Human Services

Class 2 Device Recall 5.0 mm Periprosthetic Locking Screw Selftapping 12 mm Sterile

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 Class 2 Device Recall 5.0 mm Periprosthetic Locking Screw Selftapping 12 mm Sterilesee related information
Date Initiated by FirmApril 04, 2016
Create DateApril 27, 2016
Recall Status1 Terminated 3 on September 02, 2016
Recall NumberZ-1574-2016
Recall Event ID 73770
510(K)NumberK041533 
Product Classification Screw, fixation, bone - Product Code HWC
Product5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Code Information Lot Number 5539094, Catalog ID # 02.221.462S Manufacture date 07/02/2007 Expiration date 05/31/2012
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information ContactAnne Brisson
610-719-6500
Manufacturer Reason
for Recall		This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.
FDA Determined
Cause 2		Process control
ActionDePuy Synthes mailed to customers an Urgent Notice informing them they were voluntarily recalling 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm-Sterile, part # 02.221.462S, Lot # 5539094, expiration date May 31, 2012, due to the units being shipped after the expiration date of May 31, 2012. Customers were instructed to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section on page 3 by checking the appropriate box and return the form and product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.
Quantity in Commerce15 units
DistributionDistributed in IL and IN.
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.
510(K) Database510(K)s with Product Code = HWC
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