Biomet Spine, LLC: Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.

Agency Publication Date: April 20, 2015

Affected Products

Product: Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.

538133 ,538134 ,548080 ,550475 ,552169 ,553131, 553710 ,558873 ,567568 ,569141

Product: Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.

538133,538134,548080,550475,552169,553131,553710,558873,567568,569141 Part Number: 6200-1109 2009300344 to 2009300543 2009300544 to 2009300643 2009300644 to 2009300743 2009300744 to 2009300843 2009300844 to 2009300993 2009411328 to 2009411377 2010082160 to 2010082257 2010152507 to 2010152571 2010373025 to 2010373174

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70832

Status: Resolved

Manufacturer: Biomet Spine, LLC

Manufactured In: United States

Units Affected: 2 products (148; 874)

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Sources: FDA iRES · Raw API Response

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Affected Products

538133 ,538134 ,548080 ,550475 ,552169 ,553131, 553710 ,558873 ,567568 ,569141

Product: Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.