Z-0111-2015Class II

Symmetric Total Knee Femoral Components

Name: Z-0111-2015 Symmetric Total Knee Femoral Components
Creator: Signal Medical Corporation
Published: 2014-09-30
License: https://open.fda.gov/license/

Whiteside Biomechanics, Inc. / initiated 2014-09-30 / Terminated / root cause: packaging

FDA source

Signal Medical Corporation began a recall of Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System... on 2014-09-30. FDA classified it as Class II and gives the reason as "Packaging of a device was compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0111-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-30
Posted: 2014-10-22
Terminated: 2016-03-14
Recalling firm: Whiteside Biomechanics, Inc.
Product: Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Packaging of a device was compromised
Root cause tag: packaging
FDA root cause: Packaging
Action: Signal Medical sent a Notice letter dated September 30, 2014 to customers. Customers were instructed to carefully inspect devices to ensure package integrity before using. If packaging is compromised it should not be used. Return the affected device and packaging to Signal Medical Corporation. Replacement devices with new packaging configuration is shipped to each location with the old packaging configuration in the event that the packaging is found to be compromised. For questions contact Signal Medical Corp. at 1-800-246-6324.
Quantity in commerce: 41
Distribution: Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
Product codes and lots: Catalog # 22-01-02106; Lot # 1110; Serial # L0259; Size 6R Catalog #22-01-02106; Lot # 2910; Serial # L0533; Size 6R Catalog # 22-01-02003, Serial #s L0280,L0283, L0284, L0285, L0287, L0288, L0615, Size 3 L Catalog # 22-01-02004, Serial # l0358, Size 4L Catalog # 22-01-02005, Serial # L0809; Size 5L Catalog #22-01-02006; Serial #s L0692, L0842, L0485, L0483, L0486, L0841, L0844, L0847, Size 6L Catalog # 22-01-02007, Serial #s L0721, L0786, L0787, L0770, L0772, L0775, Size 7L Catalog #22-01-02103, Serial #s L0265, L0272, Size 3R Catalog # 22-01-02104, Serial #s L0479, L0515, L0517, Size 4R Catalog # 22/01-02106, Serial # L0338, L0508, L0537, L0853, L0867, L0872, L0873, Size 6R Catalog #22-01-02107, Serial #s L0749, L0758, L0760, L0755, L0759, L0762, Size 7R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0111-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0111-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-21

Product code JWH

K080199Class IISymmetric Total Knee SystemSignal Medical Corporation / cleared 2008-07-03

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)