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U.S. Department of Health and Human Services

Class 2 Device Recall SROM distal femoral cutting block guide

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 Class 2 Device Recall SROM distal femoral cutting block guidesee related information
Date Initiated by FirmOctober 19, 2010
Date PostedFebruary 22, 2011
Recall Status1 Terminated 3 on December 03, 2012
Recall NumberZ-1389-2011
Recall Event ID 57245
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductS-ROM Distal Femoral Cutting block Guide SZ MED, REF 216311004, non-sterile, Depuy International Leeds, England. The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery.
Code Information C44AK4000, D1WL94000, DG9LA4000, DJ5EF4000, DJ5EV4000, DY6GB4000 and DP5WM4000. 
Recalling Firm/
Manufacturer		 Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactKatie Seppa
574-372-7333
Manufacturer Reason
for Recall		The firm was notified that the Hinge Block Femoral Box Guide cut being off alignment when using the S-ROM Distal Femoral Cutting Block Guide SZ SML/X-SML pin holes to locate. The firm then found that the same issue was found int the MED block size.
FDA Determined
Cause 2		Device Design
ActionThe firm, DePuy, sent an "URGENT INFORMATION - DEVICE CORRECTION" email and letter dated October 19, 2010 to all customers. The notices described the product, problem and actions to be taken by the customers. The notices stated that: Depuy is issuing a device correction; however, the product may still be used; the devices do not need to be returned; the distributors were to provide a letter to clinicians that were using the device; the surgical technique will be revised in October 2010; the product will undergo a design change, and the recalled product will be traded out in December 2010 and January 2011. If you have any additional questions, please contact DePuy's Scientific Information office at 1-888-554-2482. On 3/4/2011, The firm sent out a revised URGENT DEVICE RECALL asking that all affected cutting guides be taken out of service immediately. Devices should be returned to DePuy and new cutting guides will be sent out within 2 weeks.
Quantity in Commerce219
DistributionWorldwide distribution: USA including states of: AZ, AR, CA, CO, FL, GA, IA, ID,IL, IN, KY, KS, LA, MA, MD, MI, MN, NC, NV, PA, TN, TX, VA, WA, and WI; and countries including: Canada and Ireland. Australia, Austria, Canada, Denmark, Ireland, Israel Italy, New Zealand, Russia, Sweden, Switzerland, Spain, and UK.
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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