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Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in… recallZ-3189-2011 · The Anspach Effort, Inc. · initiated May 9, 2011

Terminated All recalls posted in September 2011

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

The Anspach Effort, Inc., Palm Beach Gardens, FL, is recalling their Anspach Single Use, Sterile Bone Cutting Burrs, catalog numbers, IMRI-S-8NS-M, M-6P, QD8-4OVD, S-5B-4, and SIL-7-9, lot #'s C323023789, C403026551, C473028567, C403026563, D153034013, D173034385, and C363024789, because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to

FDA root cause category: Employee error

What the company is doing

The Anspach Effort, Inc. sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated May 27, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and to segregate any affected product found. A Customer Response Form was attached for customers to complete and return to the firm via fax at 1-800-327-6661. Contact Anspach Customer Support at 800-327-6887 for questions regarding this recall.

Recall details

Recall number
Z-3189-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 9, 2011
Posted by the FDA
Sep 13, 2011
Recalling firm
The Anspach Effort, Inc.
Quantity
5
Product code
HBC
FDA submissions
K011444
Distribution
Worldwide Distribution--USA (nationwide) including the states of Alabama, California, and Wisconsin and the countries of Columbia, France, Germany, Great Britain, Italy, Panama, Poland, Saudi Arabia, South Africa, Spain, and Switzerland.

Product description

Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT C323023789***. Cutting and Shaping bone including bones of the spine and cranium.

Code information (models, lots, serial numbers)

Batch # - C323023789

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 58985).

Sources and updates

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