FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
- Recall number
- Z-2253-2016
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
- Status
- Terminated
- Initiated
- 2016-06-15
- Posted
- not on file
- Terminated
- 2016-12-14
- Reason
- The graphics at the attachment interface indicating locked and unlocked position are reversed.
- Root cause
- Employee error
- Action
- The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE-RECALL (Removal)" letter dated June 15, 2016 to its customers. The letter described the product, problem and actions to taken. The customers were instructed to review your inventory and immediately remove the product subject to this recall from stock; If you DO HAVE any of the identified devices, please take the following steps: " Ensure anyone in your facility impacted by this notification reads this letter carefully. Customer Letter Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating product subject to the recall has been located. Indicate the number of devices found. " The RMA information has been filled in for your convenience. " Please include your name, title, address, telephone number, signature and date in the spaces provided. " Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Department by: " Fax: (561) 627-2682 " Scan/email: DPYUS-PowerToolsFieldActions@its.jnj.com " Giving it to your DePuy Synthes Sales Consultant. " This return documentation acknowledges your receipt of medical device removal information. " Return the affected product to your DePuy Synthes Sales Consultant " Keep this notice visibly posted for awareness until all products subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this action and keep a copy for your records. If you DO NOT HAVE the identified product, please take the following steps: " Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Include your name, title, address, telephone number, signature and date in the spaces provided. " Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Department by Fax: (561) 627-2682 " Scan/email: DPYUS-PowerToolsFiel
- Quantity
- 18
- Distribution
- Worldwide Distribution: US Distribution to states of: GA and FL; and country of: Switzerland.
- Lot, serial or model codes
- Lot #'s: H29309439804, H44310033104, K09311396703, and K09311396704.
- 510(k) numbers
- ["K133604"]
- PMA numbers
- not on file
- Product code
- HBC
- Firm FEI
- 1045834
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- 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