FDA Medical Device Recalls (openFDA)
Orthofix Inc: 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.
- Recall number
- Z-0590-2011
- Recalling firm
- Orthofix Inc
- 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.
- Status
- Terminated
- Initiated
- 2010-10-18
- Posted
- 2010-12-10
- Terminated
- 2011-02-28
- Reason
- Outer cartons for the product may be labeled with incorrect needle gauge.
- 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
- 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.
- Lot, serial or model codes
- Lot numbers L0J124, L0D175, L9K206 and L9E218
- 510(k) numbers
- ["K913306"]
- PMA numbers
- not on file
- Product code
- LWE
- Firm FEI
- 2183449
- Firm city
- Lewisville
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28