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SURGIFORM
SURGICAL TECHNOLOGY LABORATORIES INC · Model AM-03 · UDI-DI 00850987007635
LZK
Prescription
1
510(k) clearances
61
Adverse events (2 deaths)
4
Recalls
8
Facilities
Description
AM-03 Anatomical Malar Silicone Implants
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-26 | DSAART LLC | Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. |
| 2007-07-24 | Spectrum Designs Inc | Mispackaging/Mislabeing: a portion of the lot may be labeled as containing nasal implants |
| 2007-07-24 | Spectrum Designs Inc | Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant. |
| 2007-06-15 | Spectrum Designs Inc | 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 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.