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ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length.… recallZ-1574-2014 · The Anspach Effort, Inc. · initiated Jan 8, 2014

Class II Terminated All recalls posted in May 2014

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

Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

FDA root cause category: Labeling mix-ups

What the company is doing

Anspach sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated January 13, 2014, to all affected customers. The letter described the product, the problem and actions to be taken. If they have distributed any of the products to other services or facilities, customers were instructed to please forward this information as appropriate. Customers with questions you contact Anspach Customer Support at (800) 327-6887, option 3 or email [email protected].. Customers were asked to complete the attached reply form confirm receipt of the letter, return the completed form by fax to 800-327-6661. For questions regarding this recall call 561-494-3706.

Recall details

Recall number
Z-1574-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 8, 2014
Posted by the FDA
May 9, 2014
Recalling firm
The Anspach Effort, Inc.
Quantity
30 cutting burs affected
Product code
HTT
FDA submissions
K011444
Distribution
Nationwide Distribution including FL, TX, NC, IL, CO, and PA.

Product description

ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.

Code information (models, lots, serial numbers)

Lot/Set/Serial: G323081803.

Other devices under the same FDA submission

29 devices cleared under K011444 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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