Z-1206-2007

Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S

Name: Z-1206-2007 Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S
Creator: Spectrum Designs Inc
Published: 2007-06-15
License: https://open.fda.gov/license/

Spectrum Designs, Inc. / initiated 2007-06-15 / Terminated / root cause: packaging

FDA source

Spectrum Designs Inc began a recall of Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S on 2007-06-15. The reason FDA records is "The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, it is assumed that...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1206-2007
Status: Terminated
Initiated: 2007-06-15
Posted: 2007-08-29
Terminated: 2012-03-07
Recalling firm: Spectrum Designs, Inc.
Product: Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.
Product code: LZK Implant, Malar
Reason for recall: The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, it is assumed that one other unit was packaged with two lefts and no right. This was discovered through a physician complaint.
Root cause tag: packaging
FDA root cause: Other
Action: The firm initiated the recall on 06/15/2007 by contacting their customers by telephone. The firm followed-up by sending recall letters via FedEx or certified mail with signature confirmation to each direct account who received the recalled product on 06/18/2007.
Quantity in commerce: 15 pairs (left/right)
Distribution: Nationwide.
Product codes and lots: Lot number 30838, serial numbers BAE256 through BAE275, manufactured June, 2006. Expiration date is five years from date of manufacture.

Product code LZK

K944165Class IISilhouette Malar ImplantSpectrum Designs, Inc. / cleared 1994-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)