—#147607

Product

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

FDA product code: HBC — Motor, Drill, Electric
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K133604
Affected lot / code info: Lot #'s: H29309439804, H44310033104, K09311396703, and K09311396704.

Why it was recalled

The graphics at the attachment interface indicating locked and unlocked position are reversed.

Root cause (FDA determination)

Employee error

Action the firm took

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

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern: Worldwide Distribution: US Distribution to states of: GA and FL; and country of: Switzerland.

Timeline

Recall initiated: 2016-06-15
Terminated: 2016-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147607. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.