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New Balance

RENFRO CORPORATION · Model N915 Black Medium · UDI-DI 00888625001608

DWL
1
510(k) clearances
72
Adverse events (3 deaths)
4
Recalls
104
Facilities

Description

Graduated Compression Support Sock Firm Support (20-30 mmHg) Over the Calf, Closed Toe

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.