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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instr

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 Class 2 Recall
Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instr
see related information
Date Posted January 18, 2012
Recall Status1 Open
Recall Number Z-0804-2012
Recall Event ID 60744
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Brand Name: Custom Straight Accolade®® Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Straight Command®® Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Straight Accolade®® Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Accolade®® Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Accolade®® Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Locking Accolade®® Straight Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Woodpecker Adapted Accolade®® Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430 The Handles are instruments that attach to the femoral rasps or broaches to prepare the Femoral Canal in total hip replacement procedures. The rasps have a geometry similar to the final size and shape of the implant. The straight design allows the rasp handle to be used in standard or minimally invasive approaches because it minimizes the contact with adjacent soft tissue. The Handle is impacted with a slotted mallet on the top and on the bottom portions of the striking plate, to achieve rasp insertion and extraction respectively. The handles share the same geometry in the region that is of interest in this matter.
Code Information 510 K exempt. All lots I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H1427HFOO "
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Ms. Colleen O'Meara
201-831-5158
Manufacturer Reason
for Recall
Stryker Orthopaedics has become ware that there is the potential for the above referenced instruments to fracture in two pieces along the width of the body under the striking plate.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Stryker Orthopaedics sent a Urgent Product Recall update dated August 18, 2011, via FedEx to all affected customers. The letter identified the product(s) the problem and the action needed to be taken by the customer. Our records indicate that you have received the above referenced product(s). It is Stryker's® responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form within 5 days to 201-831-6069. Please also contact the hospitals in your territory that have the affected product to arrange return of the product as replacement product becomes available. If you have any further questions please call (201) 831-5158.
Quantity in Commerce 106 UNITS
Distribution USA (nationwide distribution)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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