Stryker 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.
Recall
- Recall Number
- Z-0937-2015
- Event Number
- 69979
- Firm
- Orthovita, Inc., dBA Stryker Orthobiologics.
- FEI Number
- 1000307073
- Product Code
- KNW
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- December 4, 2014
- Posted
- January 7, 2015
- Terminated
- July 28, 2015
- Address
- 45 Great Valley Pkwy, Malvern, PA, 19355-1302
Description
Stryker 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.
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.
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.
Worldwide Distribution: US (nationwide) and country of: Canada.
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