Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.
FDA Recall Z-1206-2007 · Posted 2007-08-29
Recalling FirmSpectrum Designs Inc
Recall StatusTerminated
Product CodeLZK
Date Initiated2007-06-15
Date Terminated2012-03-07
Product Quantity15 pairs (left/right)
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.