Home › Aesculap AG › A-SPACE SIBD

A-SPACE SIBD

Aesculap AG · Model SJ607R · UDI-DI 04046963670306

HWJ Prescription

510(k) clearances

313

Adverse events

Recalls

321

Facilities

Description

FLEXIBLE BONE AWL

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.

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 key Read 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.