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U.S. Department of Health and Human Services

Class 2 Device Recall Imbibe Bone Marrow Aspiration Needle

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  Class 2 Device Recall Imbibe Bone Marrow Aspiration Needle see related information
Date Initiated by Firm December 04, 2014
Date Posted January 07, 2015
Recall Status1 Terminated 3 on July 28, 2015
Recall Number Z-0938-2015
Recall Event ID 69979
510(K)Number K140414  
Product Classification Instrument, biopsy - Product Code KNW
Product Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch
2090-0028 Needle (bullet-tip), 11 gauge x 6 inch
2090-0029 Needle (bullet-tip), 8 gauge x 6 inch
2090-0047 Needle (bullet-tip), 8 gauge x 8 inch
2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch

intended for use to aspirate bone marrow or autologous blood.
Code Information all lots of the Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Catalog No.: 2090-0027, 2090-0028, 2090-0029, 2090-0030, 2090-0047    
Recalling Firm/
Manufacturer		 Orthovita, Inc., dBA Stryker Orthobiologics.
45 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information Contact Customer Support
610-640-1775
Manufacturer Reason
for Recall		 There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.
FDA Determined
Cause 2		 Package design/selection
Action The firm, Stryker, sent an "URGENT PRODUCT RECALL" letter dated December 4, 2014, to end users/customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to complete and return the URGENT MEDICAL DEVICE RECALL NOTIFICATION ACKNOWLEDGMENT FORM within 5 days via fax to 215-253-5020, contact other hospitals in your territory that have the affected products to arrange return of the product, and return the affected product to: Stryker Orthobiologics, 67 Great Valley Parkway, Malvern, PA 19355. If you have any questions, feel free to contact the Associate Manager, Quality Assurance and Regulatory Compliance at 610-640-1775 x 5299.
Quantity in Commerce 89770
Distribution Worldwide Distribution: US (nationwide) and country of: Canada.
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 = KNW and Original Applicant = ORTHOVITA, INC.
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