Z-0590-2011

Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720...

Name: Z-0590-2011 Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720...
Creator: Orthofix Inc
Published: 2010-10-18
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2010-10-18 / Terminated / root cause: labeling and UDI

FDA source

Orthofix Inc began a recall of Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207... on 2010-10-18. The reason FDA records is "Outer cartons for the product may be labeled with incorrect needle gauge". 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-0590-2011
Status: Terminated
Initiated: 2010-10-18
Posted: 2010-12-10
Terminated: 2011-02-28
Recalling firm: Orthofix SRL
Product: Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and universal cap. Cannula is available as an 8 gauge needle or 11 gauge needle.
Product code: LWE Bone Marrow Collection/Transfusion Kit
Reason for recall: Outer cartons for the product may be labeled with incorrect needle gauge.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Orthofix issued an Urgent Product Recall letter dated October 14, 2010 to consignees. Customers were instructed to inspect their inventory, and remove and return affected product to the firm. Replacement needles will be provided. Orthofix account representatives can be contacted at 1 888 298 5700, and Orthofix Regulatory Affairs can be contacted at 1 214 937 2061.
Quantity in commerce: 274
Distribution: Worldwide Distribution - USA, including the states of AL, AR, CA, CT, FL, LA, MI, MO, NC, NJ, NY, PA, SC, and TX, and the country of Spain.
Product codes and lots: Lot numbers L0J124, L0D175, L9K206 and L9E218

Product code LWE

K913306Class IIBone-Temno/sternum-TemnoProact, Ltd. / cleared 1991-11-01

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)