Z-0418-2015Class II

Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a...

Name: Z-0418-2015 Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a...
Creator: Materialise USA LLC
Published: 2014-10-16
License: https://open.fda.gov/license/

Materialise USA, LLC. / initiated 2014-10-16 / Terminated / root cause: manufacturing process

FDA source

Materialise USA LLC began a recall of Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of... on 2014-10-16. FDA classified it as Class II and gives the reason as "The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0418-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-16
Posted: 2014-11-21
Terminated: 2015-02-17
Recalling firm: Materialise USA, LLC.
Product: Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Materialise USA was notified on October 16, 2014 by the Field Representative of the distributor (Zimmer) that the box of guides for case JTOMA-JL-0636-L arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. A new set of tibial and femoral guides were manufactured and sent to Zimmer (headquarters distribution center) on October 17, 2014 before the surgery date on October 20, 2014. For questions regarding this recall call 734-662-5057.
Quantity in commerce: 1
Distribution: Nationwide Distribution to MN only
Product codes and lots: 00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0418-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0418-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-21

Product code JWH

K121640Class IIZimmer Patient Specific Instruments SystemMaterialise NV / cleared 2012-12-05

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)