Z-0109-2015Class II

Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648)...

Name: Z-0109-2015 Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648)...
Creator: Signal Medical Corporation
Published: 2014-09-23
License: https://open.fda.gov/license/

Whiteside Biomechanics, Inc. / initiated 2014-09-23 / Terminated / root cause: manufacturing process

FDA source

Signal Medical Corporation began a recall of Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended... on 2014-09-23. FDA classified it as Class II and gives the reason as "Incorrect dimension on four liners was detected". 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-0109-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-23
Posted: 2014-10-22
Terminated: 2015-01-20
Recalling firm: Whiteside Biomechanics, Inc.
Product: Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Incorrect dimension on four liners was detected
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Signal Medical Corporation verbally notified the only consignee via telephone. Please call Signal Medical Corp. at 1-800-246-6324 with any questions.
Quantity in commerce: 12 devices
Distribution: US Distribution in MO only.
Product codes and lots: Catalog #: WB-1-1122, Size: 36x52x20, Serial # B13085 Catalog #. WB-1-1110 Size: 36x50x20, Serial # B13099 Catalog # WB-1-1110, Size: 36x50x20, Serial #: B13105 Catalog # WB-1-1110, Size: 36x50x20, Serial # B13106

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0109-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0109-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-21

Product code LPH

K955271Class IIMicro-Seal Acetabular SystemWhiteside Instruments / cleared 1996-01-30

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)