Home / Recalls / Instrumed International, Inc. / Z-0546-2015

Z-0546-2015 Class II Terminated

Recalled by Instrumed International, Inc. — Schaumburg, IL

FDA device recall Z-0546-2015 was initiated by Instrumed International, Inc. on Sep 8, 2014 and is designated Class II. Reason for recall: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements… The recall status is terminated (terminated Nov 29, 2017). Affected quantity: 2 D'errico perforator drills.

Recall Details

Product Type
Devices
Report Date
Dec 17, 2014
Initiation Date
Sep 8, 2014
Termination Date
Nov 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 D'errico perforator drills

Product Description

D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names.

Reason for Recall

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

Distribution Pattern

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Code Information

1) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: D'errico Perforator Drill, 16 mm; Symmetry Surgical Item Number: 57-6076; Lot Number: 110211. 2) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: Teleflex Medical; Teleflex Medical Product Name: D'errico Perforator Drill, 16 mm; Teleflex Medical Item Number: P-22893; Lot Number: 110211. 3) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: CareFusion; CareFusion Product Name: D'errico Perforator Drill, 16 mm; CareFusion Item Number: VM85-1253.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0546-2015
openFDA file date
Oct 27, 2026
Loaded by RegDataLab
Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources