PlainRecordsMicroseal Augmented (20 degrees) Liner…
- Reason
- Incorrect dimension on four liners was detected
- Status
- Terminated
- Distribution
- US Distribution in MO only.
- Enforcement report date
- Oct. 29, 2014
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Terminated (FDA's definition: FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Signal Medical Corporation
- 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.
- Reason
- Incorrect dimension on four liners was detected
- Distribution pattern
- US Distribution in MO only.
- Quantity
- 12 devices
- 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
- Recall started
- Sept. 23, 2014
- Recall terminated (FDA)
- Jan. 20, 2015
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Root cause (FDA)
- Process design
- What the company told customers
- Signal Medical Corporation verbally notified the only consignee via telephone. Please call Signal Medical Corp. at 1-800-246-6324 with any questions.
- Recall number
- Z-0109-2015
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Incorrect dimension on four liners was detected”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., FDA enforcement report, 2014-10-29. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Distributed in (FDA's record): Missouri
This recall among the others
- FDA's enforcement report came 36 days after the firm started the recall. For half of the 1,269 FDA medical device recall events reported in 2014 with a start date, it took 50 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-0109-2015. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-0109-2015, Oct. 29, 2014. "Microseal Augmented (20 degrees) Liner." PlainRecords, https://plainrecords.com/recall/device/z-0109-2015/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections