| Class 2 Device Recall TruFit | |
Date Initiated by Firm | September 29, 2006 |
Date Posted | December 30, 2006 |
Recall Status1 |
Terminated 3 on August 09, 2007 |
Recall Number | Z-0442-2007 |
Recall Event ID |
36521 |
Product Classification |
Bone plug - Product Code MQV
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Product | TruFit BGS Plug Size Code Red, 7mm; quantity 1; Part #600-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX. |
Code Information |
051024-14 and 011-051024-14. |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Drive Andover MA 01810-1031
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Manufacturer Reason for Recall | Mis-packaging-product in the package may be a different size than indicated on the labeling. |
FDA Determined Cause 2 | Other |
Action | Firm notified customers of recall by letter sent via FedEx on 09/29/06. |
Quantity in Commerce | 23 |
Distribution | Nationwide-Product distributed to distributors, sales reps and hospitals in AL, CA, FL, IL, NJ, NM, NY, PA, TX and UT. |
Total Product Life Cycle | TPLC Device Report |
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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.
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