Z-1396-2013Class II

Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number...

Name: Z-1396-2013 Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number...
Creator: Orthovita, Inc., dBA Stryker Orthobiologics.
Published: 2012-11-10
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2012-11-10 / Terminated / root cause: labeling and UDI

FDA source

Orthovita, Inc., dBA Stryker Orthobiologics. began a recall of Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of... on 2012-11-10. FDA classified it as Class II and gives the reason as "There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1396-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-10
Posted: 2013-05-24
Terminated: 2014-10-29
Recalling firm: DSM Biomedical, Inc.
Product: Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Product code: OAR Injector, Vertebroplasty (Does Not Contain Cement)
Reason for recall: There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.
Quantity in commerce: 7
Distribution: USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Product codes and lots: Manufacturer Part Number 2110-0504, Lot Number E909007R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1396-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1387-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1388-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1389-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1390-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1391-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1392-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1393-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1394-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1395-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1396-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1397-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1398-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24
Z-1399-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24

Product code OAR

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)