FDA Medical Device Recalls (openFDA)
Spectrum Designs Inc: Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.
- Recall number
- Z-1206-2007
- Recalling firm
- Spectrum Designs Inc
- Product
- Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.
- Status
- Terminated
- Initiated
- 2007-06-15
- Posted
- 2007-08-29
- Terminated
- 2012-03-07
- Reason
- 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
- 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
- 15 pairs (left/right)
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot number 30838, serial numbers BAE256 through BAE275, manufactured June, 2006. Expiration date is five years from date of manufacture.
- 510(k) numbers
- ["K944165"]
- PMA numbers
- not on file
- Product code
- LZK
- Firm FEI
- 1000125318
- Firm city
- Carpinteria
- Firm state
- CA
- 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