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U.S. Department of Health and Human Services

Class 2 Device Recall djo surgical6.5 mm cancellous bone screw

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  Class 2 Device Recall djo surgical6.5 mm cancellous bone screw see related information
Date Initiated by Firm July 16, 2012
Date Posted August 06, 2012
Recall Status1 Terminated 3 on December 04, 2012
Recall Number Z-2146-2012
Recall Event ID 62561
510(K)Number K931665  
Product Classification Screw, fixation, bone - Product Code HWC
Product djo surgical Screw 6.5 mm, Sz 25mm, low profile.

Product is intended for the fixation of the acetabular shell or fracture repair
Code Information Lot 007A1037, Ref 010-55-25.
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact Teffany Hutto
512-832-9500
Manufacturer Reason
for Recall		 One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.
FDA Determined
Cause 2		 Packaging
Action DJO Global sent an Urgent Field Safety Notice dated July 16, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the notice to all thoe who need to be aware within their organization or to any other organization where the potentially affected product was transferred, contact customers to place a replacement order and receive an RMA number, and return all affected devices using the RMA number. For questions customers should call 512-834-6255. For questions regarding this recall call 512-832-9500.
Quantity in Commerce 18 devices
Distribution Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HWC and Original Applicant = ENCORE ORTHOPEDICS, INC.
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