Date Initiated by Firm |
July 11, 2008 |
Date Posted |
September 18, 2008 |
Recall Status1 |
Terminated 3 on September 20, 2011 |
Recall Number |
Z-2375-2008 |
Recall Event ID |
49018 |
510(K)Number |
K053228
|
Product Classification |
Calcium Compound Bone Void Filler - Product Code MQV
|
Product |
FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100
Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates. |
Code Information |
Lot # A08F01E Exp Date 2010-06 |
Recalling Firm/ Manufacturer |
Theken Spine LLC 1800 Triplett Blvd Akron OH 44306-3311
|
For Additional Information Contact |
Suzanne Wojcik 330-475-8643
|
Manufacturer Reason for Recall |
The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
In a letter dated July 11, 2008, the firm asked their customers to check their inventory for the suspect product. If found they are to return the product for credit or replacement. The firms asks customers to contact them if any units were used for surgery and they will send the correct patient labels. If additional information is needed, customers are to contact Theken Spine Regulatory Affairs or the Quality Department. |
Quantity in Commerce |
33 syringes |
Distribution |
Nationwide Distribution --- including states of FL, OH, TX, and UT. |
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 = MQV and Original Applicant = THERICS, LLC
|