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ANSPACH - 5MM x 11.3MM Fluted Barrel recallZ-2296-2015 · The Anspach Effort, Inc. · initiated Apr 13, 2015

Class II Terminated All recalls posted in July 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from The Anspach Effort, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.

FDA root cause category: Device Design

What the company is doing

Anspach sent an Urgent Notice: Medical Device Recall (Correction) letter of Anspach G1 Dissection Tools dated May 6, 2015, to all affected customers. Customers were not required to return their inventory of GI Dissection tools. Customers were instructed to complete, sign, and return the attached reply form confirming receipt of the letter by fax or email. Customers were also instructed to forward the letter as appropriate immediately. Customers with questions should contact the Complaint Handling Unit Manager at 561-494-3673 or contact their Anspach Sales Representative. For questions regarding this recall call 561-627-1080.

Recall details

Recall number
Z-2296-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 13, 2015
Posted by the FDA
Jul 29, 2015
Recalling firm
The Anspach Effort, Inc.
Quantity
103 tools.
Product code
HBE
FDA submissions
K113476
Distribution
Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.

Product description

ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.

Code information (models, lots, serial numbers)

REF M-5BA-A-G1 ; ALL lot numbers

Other devices under the same FDA submission

47 devices cleared under K113476 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 71212).

Sources and updates

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