FDA Device recall Z-0548-2015

Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a…

FDA Device
Class II
terminated
Published 2014-12-17

On 2014-12-17 the FDA classified a Class II recall of Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a… by Instrumed International, citing the reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0548-2015
Classification	Class II
Status	terminated
Initiated	2014-09-08
Published	2014-12-17
Last updated	2026-09-13 11:53 UTC
Company	Instrumed International
Distribution	US

Product

Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.

Reason

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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

Identifiers

code_info	1) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616;… 1) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Symmetry Surgical Item Number: 57-6000; Lot Number: 110212. 2) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Medfix International; Medfix International Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Medfix International Item Number: MF223-1672; Lot Number: 110212. 3) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Stealth Surgical Item Number: SS2135; Lot Number: 110212. 4) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrum

code_info

1) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616;…

1) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Symmetry Surgical Item Number: 57-6000; Lot Number: 110212. 2) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Medfix International; Medfix International Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Medfix International Item Number: MF223-1672; Lot Number: 110212. 3) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Stealth Surgical Item Number: SS2135; Lot Number: 110212. 4) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrum

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0548-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.