Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for t

FDA device recall Z-0162-2016 · posted 2015-10-23 · Terminated

Recall details

Recalling firm

Materialise N.V.

Reason for recall

Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.

Action taken

On September 16, 2015 Materialise NV identified four cases where not all available image sets were used to design the case. On September 18, 2015, prior to the surgery dates Materialise informed (phone call) the Signature Services Manager of Zimmer Biomet that inaccuracies in the alignment of the knee might be observed with the use of the guides due to this issue. Biomet was asked to segregate the packages for these four cases and to return them to the Materialise US office. On September 23, 2015 this was followed up by e-mail notification letter with response forms. Biomet was requested to contact Materialise customer service to return these four cases and arrange a replacement set of patient specific surgical guides Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. E-mail : ortho-quality@materialise. be Customer Service Materialise USA LLC 44650 Helm Court Plymouth, Michigan 48170 734-259-7033

Root cause

Use error

Status

Terminated

Product code

OSF

Quantity affected

4

Distribution

Distributed in MI, ID, TX, and in France.

Date initiated

2015-09-23

Date posted

2015-10-23

Date terminated

2016-02-12

Location

Heverlee, Belgium

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