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LINK Instruments - Retractors, bone levers, elevators

WALDEMAR LINK GmbH & Co. KG · Model 64-4161/09 · UDI-DI 04026575286249

GDG Prescription

510(k) clearances

277

Adverse events

Recalls

313

Facilities

Description

Orthopaedic prosthesis instrument, reusable - General Instrument

Recalls

Date	Firm	Reason
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2024-11-12	MEDLINE INDUSTRIES, LP - Northfield	Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
2024-02-23	MEDLINE INDUSTRIES, LP - Northfield	Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2011-12-06	Teleflex Medical	Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there
2011-12-06	Teleflex Medical	Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there
2008-05-12	Telefelx Medical	The bands are breaking within the sealed packaging or in use prior to the expiration dates.
2008-05-12	Telefelx Medical	The bands are breaking within the sealed packaging or in use prior to the expiration dates.

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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.