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Truform®

SURGICAL APPLIANCE INDUSTRIES, INC. · Model 0810BL-XL · UDI-DI 00048503281069

DWL

510(k) clearances

Adverse events (3 deaths)

Recalls

105

Facilities

Recalls

Date	Firm	Reason
2014-03-19	Zimmer, Inc.	During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
2014-03-19	Zimmer, Inc.	During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
2014-03-19	Zimmer, Inc.	During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
2014-03-19	Zimmer, Inc.	During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

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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.