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U.S. Department of Health and Human Services

Class 2 Device Recall Imbibe Aliquot Needle Bone Cement Needle

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 Class 2 Device Recall Imbibe Aliquot Needle Bone Cement Needlesee related information
Date Initiated by FirmDecember 04, 2014
Date PostedJanuary 07, 2015
Recall Status1 Terminated 3 on July 28, 2015
Recall NumberZ-0937-2015
Recall Event ID 69979
Product Classification Instrument, Biopsy - Product Code KNW
ProductStryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.
Code Information all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.        
Recalling Firm/
Manufacturer		 Orthovita, Inc., dBA Stryker Orthobiologics.
45 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information ContactCustomer 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 Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.
FDA Determined
Cause 2		Package design/selection
ActionThe 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 Commerce2155
DistributionWorldwide Distribution: US (nationwide) and country of: Canada.
Total Product Life CycleTPLC 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.
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