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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Saw Blade Procedure Pack

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 Class 2 Recall
Surgical Saw Blade Procedure Pack
see related information
Date Posted April 17, 2013
Recall Status1 Terminated on January 13, 2014
Recall Number Z-1127-2013
Recall Event ID 64646
Premarket Notification
510(K) Number
K911902 
Product Classification Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented - Product Code HSD
Product The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Code Information Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
Recalling Firm/
Manufacturer
Synvasive Technology Inc
4925 Robert J Mathews Pkwy
El Dorado Hills, California 95762-5701
For Additional Information Contact Dona Reust
574-972-4316
Manufacturer Reason
for Recall
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action An Urgent Medical Device Recall Notice letter dated March 21, 2013 was sent to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use; remove the products from inventory and complete and return the attached Response Form. For questions call 574-372-1570.
Quantity in Commerce 100 kits
Distribution USA Nationwide Distributor including the state of IN
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 = HSD and Original Applicant = SIERRA SURGICAL, INC.
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