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U.S. Department of Health and Human Services

Class 2 Device Recall Zweimueller Type Stem SCS

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 Class 2 Device Recall Zweimueller Type Stem SCSsee related information
Date Initiated by FirmFebruary 20, 2013
Date PostedMay 24, 2013
Recall Status1 Terminated 3 on March 26, 2014
Recall NumberZ-1385-2013
Recall Event ID 64588
510(K)NumberK110245 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductZweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem SCS-Standard Sz 5 Zweimueller Type Stem SCS-Standard Sz 6 Zweimueller Type Stem SCS-Standard Sz 7 Zweimueller Type Stem SCS-Standard Sz 8 Zweimueller Type Stem SCS-Standard Sz 9 Zweimueller Type Stem SCS-Standard Sz 10 Zweimueller Type Stem SCL-Lateralized Sz 3 Zweimueller Type Stem SCL-Lateralized Sz 4 Zweimueller Type Stem SCL-Lateralized Sz 5 Zweimueller Type Stem SCL-Lateralized Sz 6 Zweimueller Type Stem SCL-Lateralized Sz 7 Zweimueller Type Stem SCL-Lateralized Sz 8 Zweimueller Type Stem SCL-Lateralized Sz 9 Zweimueller Type Stem SCR-Revision Sz 3 Zweimueller Type Stem SCR-Revision Sz 4 Zweimueller Type Stem SCR-Revision Sz 5 Zweimueller Type Stem SCR-Revision Sz 6 Zweimueller Type Stem SCR-Revision Sz 7 Zweimueller Type Stem SCR-Revision Sz 8 Zweimueller Type Stem SCR-Revision Sz 9 Zweimueller Type Stem SCR-Revision Sz 10 Zweimueller Type Stem SCR-Revision Sz 11 Variety of hip and knee implants and instruments, multiple uses.
Code Information Part No. 120.00.15 120.00.00 120.00.01 120.00.02 120.00.03 120.00.04 120.00.05 120.00.06 120.00.07 120.00.08 120.00.09 120.00.10 123.00.03 123.00.04 123.00.05 123.00.06 123.00.07 123.00.08 123.00.09 126.00.03 126.00.04 126.00.05 126.00.06 126.00.07 126.00.08 126.00.09 126.00.10 126.00.11 
Recalling Firm/
Manufacturer		 Orthopedic Alliance LLC
26157 Jefferson Ave
Murrieta CA 92562-9561
For Additional Information Contact
909-304-9001
Manufacturer Reason
for Recall		The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
FDA Determined
Cause 2		Labeling design
ActionA recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Quantity in Commerce50 units
DistributionNationwide Distribution including the states of CA, MD, TX, NV, and WI.
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 = LZO
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