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.
|