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Sklar Instruments

SKLAR CORPORATION · Model 96-2591A · UDI-DI 10649111487828

HXK Prescription
5
510(k) clearances
114
Adverse events
5
Recalls
242
Facilities

Description

ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2023-05-18Aesculap Implant Systems LLCIncorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
2020-08-17ArthroCare CorporationDue to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless
2019-09-25Aesculap Implant Systems LLCNeedleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
2011-11-08DePuy Orthopaedics, Inc.DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the i

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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.