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.
FDA Recall Z-0590-2011 · Posted 2010-12-10
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Recalling FirmOrthofix Inc
Recall StatusTerminated
Product CodeLWE
Date Initiated2010-10-18
Date Terminated2011-02-28
Product Quantity274
Reason for Recall
Outer cartons for the product may be labeled with incorrect needle gauge.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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