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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 Device Recall Surgical Saw Blade Procedure Pack see related information
Date Initiated by Firm March 14, 2013
Date Posted April 17, 2013
Recall Status1 Terminated 3 on January 13, 2014
Recall Number Z-1127-2013
Recall Event ID 64646
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 CA 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		 Packaging change control
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 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) Database 510(K)s with Product Code = HSD and Original Applicant = SIERRA SURGICAL, INC.
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