Z-0162-2016Class II

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

Name: Z-0162-2016 Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical...
Creator: Materialise N.V.
Published: 2015-09-23
License: https://open.fda.gov/license/

Materialise N.V. / initiated 2015-09-23 / Terminated

FDA source

Materialise N.V. began a recall of Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty... on 2015-09-23. FDA classified it as Class II and gives the reason as "Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0162-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-23
Posted: 2015-10-23
Terminated: 2016-02-12
Recalling firm: Materialise N.V.
Product: Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
Product code: OSF Patient Specific Manual Orthopedic Stereotaxic System
Reason for recall: Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
FDA root cause: Use error
Action: 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
Quantity in commerce: 4
Distribution: Distributed in MI, ID, TX, and in France.
Product codes and lots: 42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0162-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0162-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-23

Product code OSF

K102795Class IISignature Planner; Signature GuidesMaterialise NV / cleared 2011-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)