Symmetry Karlin™ Stiletto 46-3052Recalls & reported problems

Aspen Surgical Products, Inc. · Symmetry® Karlin Osteotome, Curved, 3/8 Tip · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887482014011), received between Aug 23, 2022 and Aug 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Material Fragmentation1
Use of Device Problem1

Patient problems

Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 23, 2022Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem
THE CUSTOMER ALLEGED THAT DURING THE REMOVAL OF POSTERIOR SPINAL HARDWARE T9 TO L1 A PIECE OF THE OSTEOTOME INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE SURGEON STATED THAT AT ONE POINT A SMALL PIECE OF THE STRAIGHT OSTEOTOME CHIPPED OFF IN AN ATTEMPT TO LEVER THE ACROSS CONNECTOR OFF OF THE ROD. THE PIECE WAS REMOVED FROM THE SURGICAL SITE AFTER LOOKING FOR IT. HOWEVER, AN X-RAY WAS PERFORMED AND CONFIRMED THAT THERE WAS 1MM SIZE PIECE STILL REMAINING INSIDE THE PATIENT. THE SURGEON DETERMINED THAT A SECOND SURGERY WAS NOT NEEDED TO REMOVE THE 1MM PIECE. THERE WAS NO ADDITIONAL HARM TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 15279912 ↗

Device details

UDI-DI	`00887482014011`
Brand	Symmetry Karlin™ Stiletto
Model	46-3052
Company	Aspen Surgical Products, Inc.
Product code	HWM · Osteotome
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 29, 2025

Device type (GMDN): Orthopaedic osteotome

A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Other Osteotome devices

NA 2598-07-530
Depuy (Ireland) · OSTEOTOME
86 reports
NA 2002-31-000
Depuy (Ireland) · OSTEOTOME
61 reports
Watson Extraction System 17601
Depuy (Ireland) · Osteotome
60 reports
MORELAND 2422-10-000
Depuy Orthopaedics, Inc. · OSTEOTOME
53 reports
SIGMA 2024-47-111
Depuy (Ireland) · OSTEOTOME
43 reports
Watson Extraction System 17001
Depuy (Ireland) · Osteotome
41 reports
CS-PLUS/CSL-PLUS 75002165
Smith & Nephew, Inc. · OSTEOTOME
35 reports
NA 2002-25-000
Depuy (Ireland) · OSTEOTOME
31 reports

All Osteotome devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page