Signal Medical Recalls Microseal Hip Liners Due to Incorrect Dimensions
Signal Medical Corporation is recalling 12 Microseal Augmented acetabular liners because four units were found to have incorrect dimensions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level where the use of the product may cause temporary or medically reversible health consequences. No injuries or illnesses are reported in the source text.
Plain-English summary
Signal Medical Corporation is recalling 12 units of the Microseal Augmented (20 degrees) Liner, an acetabular liner component made from UHMW polyethylene. The device is intended for use with the Micro-Seal Shell in an uncemented Total Hip Replacement. The recall involves specific sizes 36x52x20 and 36x50x20.
The recall was initiated because incorrect dimensions were detected on four of the liners. The affected devices were distributed only in Missouri. Specific catalog numbers and serial numbers for the recalled units are listed in the official recall notice.
Consumers and healthcare providers should stop using the affected devices and contact Signal Medical Corporation for further instructions on replacement or return.
The recalled product
- 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…
- Manufacturer
- Signal Medical Corporation
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
- Serial # B13106
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Signal Medical Corporation
See all →- HighSignal Medical Soft Face Mallet Recalled for Tip Detachment Risk
FDA (Devices) · 2017-04-26
- ModerateSignal Medical Recalls Total Knee Femoral Components Due to Packaging Compromise
FDA (Devices) · 2014-10-29
Same hazard · dimensional defect
See all →- HighMedline ENFit G-tube connectors may leak from dimensional specification failure
FDA (Devices) · 2026-04-08
- HighMedline ENFit G-tube connector kits may leak from dimensional defect
FDA (Devices) · 2026-04-08
- HighAesculap MINOP trocar shafts may be longer than specified
FDA (Devices) · 2026-03-11
- ModerateMedline Soft Liner Dimensional Variation May Affect Outer Canister Fit
FDA (Devices) · 2024-08-28
- ModerateMedical Device Liner Recalled for Dimensional Variation Affecting Fit
FDA (Devices) · 2024-08-28
Similar recalls
- ModerateSmith & Nephew Recalls R3 XLPE Acetabular Liners Due to Mislabeling
FDA (Devices) · 2013-08-14
- HighSmith & Nephew Recalls R3 XLPE Acetabular Liners Due to Packaging Error
FDA (Devices) · 2013-08-14
- ModerateDJO Surgical Recalls Mispackaged Acetabular Liners for Hip Replacement
FDA (Devices) · 2014-03-12
- HighSmith & Nephew Recalls Reflection Acetabular Liners Due to Tolerance Issues
FDA (Devices) · 2014-01-01
- HighDePuy Altralinked Polyethylene Liners Recalled for Incorrect Size Labeling
FDA (Devices) · 2012-08-29
- HighSmith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect
FDA (Devices) · 2015-06-17