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SWANSON

WRIGHT MEDICAL TECHNOLOGY, INC. · Model 4520003 · UDI-DI 00840420121646

KYI Prescription
10
510(k) clearances
345
Adverse events
5
Recalls
22
Facilities

Recalls

DateFirmReason
2016-11-08Wright Medical Technology, Inc.The firm discovered a lack of adequate documentation confirming sterility on certain products.
2013-06-03Integra LifeSciences Corp.As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content
2010-07-12Ascension Orthopedics, IncTwo different product lots were found to be incorrectly labeled and placed into the incorrect box.
2010-07-12Ascension Orthopedics, IncTwo different product lots were found to be incorrectly labeled and placed into the incorrect box.
2003-01-24Avanta Orthopaedics, Inc.Wrong silicone elastomer used in construction.

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Data 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.