FDA Device Intelligence
HomeWALDEMAR LINK GmbH & Co. KG › LINK Instruments - Fixation instruments

LINK Instruments - Fixation instruments

WALDEMAR LINK GmbH & Co. KG · Model 319-582/00 · UDI-DI 04026575436828

HXQ Prescription
0
510(k) clearances
13
Adverse events
1
Recalls
52
Facilities

Description

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile - General Instrument

Recalls

DateFirmReason
2014-09-26Biomet, Inc.An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.