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.
This recall has been terminated (originally issued December 10, 2010).
- Company
- Orthofix, Inc
- Recall Initiated
- October 18, 2010
- Posted
- December 10, 2010
- Terminated
- February 28, 2011
- Recall Number
- Z-0590-2011
- Quantity
- 274
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Outer cartons for the product may be labeled with incorrect needle gauge.
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.
Lot / Code Info
Lot numbers L0J124, L0D175, L9K206 and L9E218
Root Cause
Other
Action Taken
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.
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