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COSY

SIGNUS Medizintechnik GmbH · Model Palm handle, awl · UDI-DI 04047844111444

HWJ Prescription

510(k) clearances

313

Adverse events

Recalls

321

Facilities

Description

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

Recalls

Date	Firm	Reason
2024-06-04	SEASPINE ORTHOPEDICS CORPORATION	Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
2023-07-07	Alphatec Spine, Inc.	Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments la
2020-04-13	K2M, Inc	The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
2020-04-13	K2M, Inc	The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
2020-04-13	K2M, Inc	The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
2020-04-13	K2M, Inc	The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
2020-04-13	K2M, Inc	The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
2020-04-13	K2M, Inc	The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
2020-04-13	K2M, Inc	The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
2020-04-13	K2M, Inc	The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.

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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.