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A PLUS®

KNIT-RITE, INC · Model 1KL40B18 · UDI-DI 00674854005261

DWLFQL
10
510(k) clearances
70
Adverse events (3 deaths)
4
Recalls
105
Facilities

Description

A PLUS 4PLY ARM# B-18 5.5" TOP 3.5" TOE X 18

Recalls

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