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Terminated

Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.

FDA Recall Z-2292-2013 · Posted 2013-09-27

Recalling FirmEbi, Llc
Recall StatusTerminated
Product CodeMAX
Date Initiated2013-04-09
Date Terminated2014-06-17
Product Quantity1730 units

Reason for Recall

Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.

Firm Action

Biomet LLC sent "Urgent Medical Device Recall" letters/fax back response forms on Tuesday April 9, 2013 via Fed Ex to all distributors. The notification identified the problem, product involved, and risk factors. In addition, the notification provides instructions to the representatives on how to return the product to EBI, LLC. Surgeons that have implanted the product were contacted on April 12, 2013.

Root Cause

Process control

Distribution Pattern

Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093629SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEMBiomet Spine · 2010-03-09

Official Source

View FDA Recall →

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

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