CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report
brochure Silhouette Sutures are for use recalled by Silhouette Lift
Silhouette Lift is recalling Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to, distributed nationwide in the US. The recall was initiated on 2 Jul 2015 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-2208-2015
- FDA event ID
- 71615
- Recalling firm
- Silhouette Lift, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jul 2015
- FDA classified
- 23 Jul 2015
- Reported
- 29 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 2 Jul 2015 | Recall initiated by company | |
| 23 Jul 2015 | Classified by FDA | +21 days |
| 29 Jul 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
Where it was distributed
US Distribution to the states of : CA, TX, IA, MA, RI, GA, WI, PA, VA, MO, FL, NE, MI, NY and CO., and Internationally to Canada.
Nationwide CaliforniaColoradoFloridaGeorgiaIowaMassachusettsMichiganMissouriNebraskaNew YorkPennsylvaniaRhode IslandTexasVirginiaWisconsin
Questions about this recall
Is brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek recalled?
Yes. Silhouette Lift recalled brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek on 2 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-2208-2015.
Why was it recalled?
Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product.
Which lots are affected?
n/a. This action does not involve recall or correction of any device. Only marketing materials are being considered in this action
Where was it sold?
US Distribution to the states of : CA, TX, IA, MA, RI, GA, WI, PA, VA, MO, FL, NE, MI, NY and CO., and Internationally to Canada.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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