FDA Medical Device Recalls (openFDA)
Signal Medical Corporation: 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).
- Recall number
- Z-0111-2015
- Recalling firm
- Signal Medical Corporation
- 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).
- Status
- Terminated
- Initiated
- 2014-09-30
- Posted
- 2014-10-22
- Terminated
- 2016-03-14
- Reason
- Packaging of a device was compromised
- 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
- 41
- Distribution
- Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K080199"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3002477077
- Firm city
- Marysville
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28