Z-2253-2016Class II

Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones...

Name: Z-2253-2016 Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones...
Creator: The Anspach Effort, Inc.
Published: 2016-06-15
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2016-06-15 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine on 2016-06-15. FDA classified it as Class II and gives the reason as "The graphics at the attachment interface indicating locked and unlocked position are reversed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2253-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-15
Posted: 2016-07-21
Terminated: 2016-12-14
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.
Product code: HBC Motor, Drill, Electric
Reason for recall: The graphics at the attachment interface indicating locked and unlocked position are reversed.
Root cause tag: manufacturing process
FDA 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: [email protected] " 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 in commerce: 18
Distribution: Worldwide Distribution: US Distribution to states of: GA and FL; and country of: Switzerland.
Product codes and lots: Lot #'s: H29309439804, H44310033104, K09311396703, and K09311396704.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2253-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2253-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-21

Product code HBC

K133604Class IIAnspach Eg1 High Speed System, G1 AttachmentsThe Anspach Effort, Inc. / cleared 2014-01-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)