Food, drugs, devices › Biomet, Inc.
Device recall: G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
FDA enforcement event 68310 is a device recall by Biomet, Inc. of Warsaw, IN, initiated 7 May 2014 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 30 Oct 2015. Initiation: voluntary: firm initiated. Biomet, Inc. has 84 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Biomet, Inc., Warsaw, IN.
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."
Distribution
"Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1837-2014 | G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458. | 1047 total | Class II | Terminated | 25 Jun 2014 |
| Z-1838-2014 | G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500. | 1047 total | Class II | Terminated | 25 Jun 2014 |
Context
Other enforcement events for Biomet, Inc.
All 84 events for Biomet, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Oct 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.