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Recall Observatory FDA recall evidence

Device product

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.

Z-0937-2015

December 04, 2014

Class II

Product summary

Firm
Orthovita, Inc., dBA Stryker Orthobiologics.
Event
Event 69979
Status
Terminated
Classification
Class II
Quantity
2155
Official record key
device-enforcement:Z-0937-2015

Official wording

Reason: 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.

Code information: all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.

Distribution pattern: Worldwide Distribution: US (nationwide) and country of: Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.