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Terminated

Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655

FDA Recall Z-1264-2007 · Posted None

Recalling FirmSpectrum Designs Inc
Recall StatusTerminated
Product CodeLZK
Date Initiated2007-07-24
Date Terminated2011-07-29
Product Quantity130

Reason for Recall

Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant.

Firm Action

The firm initiated the recall on 07/24/2007 by contacting the customer (distributor) who filed the original complaint of mislabeling by email. The firm followed-up by sending recall letters (dated July 24, 2007) via FedEx or certified mail with signature confirmation to the one other direct account who received the recalled product on 08/03/2007. Customers were instructed to check their inventory for mislabeled products and call Spectrum at (800)239-6399 to report the number of this product being returned. They were given an address for product return. The firm indicated they will examine returned products, and scrap after examination.

Root Cause

Other

Distribution Pattern

Nationwide: California and China

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944166DORSAL COLUMELLA IMPLANTSpectrum Designs, Inc. · 1994-11-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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