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U.S. Department of Health and Human Services

Class 2 Device Recall 3.5mm LCP Periarticular Proximal Humerus Plates

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 Class 2 Recall
3.5mm LCP Periarticular Proximal Humerus Plates
see related information
Date Posted November 02, 2010
Recall Status1 Open
Recall Number Z-0309-2011
Recall Event ID 56837
Premarket Notification
510(K) Number
K082625 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product 3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone
Code Information Catalog/model numbers: 02.123.020, 02.123.020S, 02.123..021, 02.123.021S, 02.123.022, 02.123.022S, 02.123.023, 02.123.023S, 02.123.024, 02.123.024S, 02.123.025, 02.123.025S, 02.123.026, 02.123.026S, 02.123.027, 02.123.027S, 02.123.028, 02.123.028S, 02.123.029, 02.123.029S, 02.123.030, 02.123.030S, 02.123.031, 02.123.031S, 02.123.032, 02.123.032S, 02.123.033, 02.123.033S, 02.123.040, 02.123.040S, 02.123.041, 02.123.041S, 02.123.042, 02.123.042S, 02.123.043, and 02.123.043S. Lot numbers range form 6371761 through 6443098.
Recalling Firm/
Manufacturer
Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Synthes Trauma Sales Consultant
800-620-7025 Ext. 5403
Manufacturer Reason
for Recall
screw can pass through plate hole
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Synthes (USA) notified all Synthes Trauma Hospital accounts of record of this recall via an Urgent Medical Device Recall letter dated September 27, 2010. The notification included instructions for hospital accounts to immediately cease use of the product, examine inventory, remove the 3.5 mm LCP Periarticular Proximal Humerus Plates from their shelves and complete and return the attached Verification Section form via mail: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132; fax: 610-215-9005 or Scan/email: FieldAction@synthes.com. If they have any of the identified devices, they were to call Synthes at 1-800-479-6329 to obtain Authorization number prior to completing Verification form. If you have any questions, please call 1-800-620-7025 x5403 or contact your Synthes Trauma Sales Consultant.
Quantity in Commerce 2849 units
Distribution Worldwide distribution: USA and countries including: Bermuda, Korea, Italy, Japan, Georgia, Qatar and Turkey
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.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = SYNTHES (USA)
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