Food, drugs, devices › Biomet, Inc.
Device recall: Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
Biomet, Inc. (Warsaw, IN) initiated this device recall on 28 Jul 2015; FDA lists 1 product record under event 71850, classified Class II.
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 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 17 May 2016. 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
"The device was assembled without screw hole plugs."
Distribution
"Distributed in Canada and Japan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2483-2015 | Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. | 5 | Class II | Terminated | 9 Sep 2015 |
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: "The device was assembled without screw hole plugs."
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: "Distributed in Canada and Japan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 May 2016. "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.