Z-0937-2015Class II

Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11...

Name: Z-0937-2015 Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11...
Creator: Orthovita, Inc., dBA Stryker Orthobiologics.
Published: 2014-12-04
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2014-12-04 / Terminated / root cause: packaging

FDA source

Orthovita, Inc., dBA Stryker Orthobiologics. began a recall of 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... on 2014-12-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0937-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-04
Posted: 2015-01-07
Terminated: 2015-07-28
Recalling firm: DSM Biomedical, Inc.
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.
Product code: KNW Instrument, Biopsy
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.
Root cause tag: packaging
FDA root cause: 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: 2155
Distribution: Worldwide Distribution: US (nationwide) and country of: Canada.
Product codes and lots: all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0937-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0937-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-07
Z-0938-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-07

Product code KNW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)