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Wiggins medical

Ebner Medical, LLC · Model 90-401-WM7 · UDI-DI 00840217909952

HCF
5
510(k) clearances
635
Adverse events (6 deaths)
5
Recalls
164
Facilities

Description

Bayonet Rotatable knot Pusher with 16mm length,3mm shaft

Recalls

DateFirmReason
2023-12-29Aesculap IncNeedle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short
2023-12-29Aesculap IncNeedle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short
2020-07-08New Wave Endo-Surgical, Corp.The plastic housing on the device may fracture
2016-11-16Teleflex MedicalThe devices wings may become partially detached from the EFx Shield during use.
2016-03-24Teleflex MedicalIncorrect expiration date was printed on the product label.

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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.