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.
FDA Recall Z-0937-2015 · Posted 2015-01-07
Advertisement
Recalling FirmOrthovita, Inc., dBA Stryker Orthobiologics.
Recall StatusTerminated
Product CodeKNW
Date Initiated2014-12-04
Date Terminated2015-07-28
Product Quantity2155
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.
Firm 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.
Root Cause
Package design/selection
Distribution Pattern
Worldwide Distribution: US (nationwide) and country of: Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement