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Terminated

Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14

FDA Recall Z-0503-2010 · Posted 2009-12-14

Recalling FirmAlphatec Spine, Inc.
Recall StatusTerminated
Product CodeKWP
Date Initiated2009-08-05
Date Terminated2010-06-07
Product Quantity158 units

Reason for Recall

Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.

Firm Action

Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.

Root Cause

Process control

Distribution Pattern

Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071380MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEMAlphatec Spine, Inc. · 2007-08-20K052201SOLANAS POSTERIOR STABILIZATION SYSTEMAlphatec Spine, Inc. · 2005-11-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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