FDA Medical Device Recalls (openFDA)
Instrumed International, Inc.: 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.
- Recall number
- Z-0546-2015
- Recalling firm
- Instrumed International, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-09-08
- Posted
- 2014-12-16
- Terminated
- 2017-11-29
- 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- The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
- Root cause
- No Marketing Application
- Action
- Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
- Quantity
- 2 D'errico perforator drills
- Distribution
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HBG
- Firm FEI
- 1421101
- Firm city
- Schaumburg
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28