Z-1837-2014Class II

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

Name: Z-1837-2014 G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458
Creator: Biomet, Inc.
Published: 2014-05-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-05-07 / Terminated

FDA source

Biomet, Inc. began a recall of G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458 on 2014-05-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1837-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-07
Posted: 2014-06-19
Terminated: 2015-10-30
Recalling firm: Zimmer GmbH
Product: G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
Product code: PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
Reason for recall: 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: Use error
Action: 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.
Quantity in commerce: 1047 total
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.
Product codes and lots: PN:110003458. Lots 424960, ZB130702, ZB130703, ZB130704, ZB130705, ZB130701, ZB131201, 360877, 377304 and ZB140201.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1837-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1837-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-19
Z-1838-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-19

Product code PBI

K121874Class IIG7 Acetabular SystemBiomet Manufacturing Corp / cleared 2012-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)