CLASS II Device recall · Reported 29 Oct 2014 · FDA Enforcement Report
Symmetric Total Knee Femoral Components recalled by Signal Medical
Signal Medical is recalling Symmetric Total Knee Femoral Components, distributed nationwide in the US. The recall was initiated on 30 Sep 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0111-2015
- FDA event ID
- 69420
- Recalling firm
- Signal Medical, Marysville, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Sep 2014
- FDA classified
- 21 Oct 2014
- Reported
- 29 Oct 2014
- Type
- Voluntary: Firm initiated
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 30 Sep 2014 | Recall initiated by company | |
| 21 Oct 2014 | Classified by FDA | +21 days |
| 29 Oct 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packaging of a device was compromised
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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).
Where it was distributed
Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
Questions about this recall
Why was it recalled?
Packaging of a device was compromised
Which lots are affected?
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
Where was it sold?
Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Signal Medical
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Soft Face "No Bounce" Mallet recalled by Signal Medical | Signal Medical | Foreign Material | Nationwide |
| Device | CLASS II | Microseal Augmented (20 degrees) Liner recalled by Signal Medical | Signal Medical | Packaging Defects | MO |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |