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G7 Acetabular System Positioning Guide Rod, orthopedic… recallZ-1837-2014 · Biomet, Inc. · initiated May 7, 2014

Class II Terminated All recalls posted in June 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 Biomet, 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

Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

FDA root cause category: Use error

What the company is doing

The firm issued the following notice on May 7, 2014: URGENT MEDICAL DEVICE RECALL NOTICE: This notification is to inform you of an Urgent Medical Device Recall initiated by Biomet Orthopedics ("Biomet") which involves Part Numbers: 110003458 G7 Positioning Guide Rod and 110003500 G7 Positioning Guide Post. These instruments have been consigned and/or invoiced to your account. Biomet has initiated this action following an investigation which identified that positioning guide rod may fracture during impaction of the acetabula shell. If the positioning guide rod fractures, then the positioning guide post may become stuck to the insertion handle. There is no adverse health outcome expected for the patient. This action requires the immediate location and discontinued use of the product and its return to Biomet. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Carefully follow the instructions on the enclosed "FAX Back Response Form. Fax a copy of the Response Form to 574-372-1683 prior to return of product. Use priority carrier for your shipment. If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear Risk/Recall Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products.

Recall details

Recall number
Z-1837-2014
Recall class
Class II
Status
Terminated
Initiated by the company
May 7, 2014
Posted by the FDA
Jun 19, 2014
Recalling firm
Biomet, Inc.
Quantity
1047 total
Product code
PBI
FDA submissions
K121874
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.

Product description

G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.

Code information (models, lots, serial numbers)

PN:110003458. Lots 424960, ZB130702, ZB130703, ZB130704, ZB130705, ZB130701, ZB131201, 360877, 377304 and ZB140201.

Other devices under the same FDA submission

62 devices cleared under K121874 — 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 68310).

Sources and updates

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