G7 APICAL HOLE PLUG 010000994Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304527423), received between Jan 20, 2020 and Jan 20, 2020 — classified as 1 injury.
3 other recalls cover devices cleared under the same FDA submission (K121874); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Extraskeletal ossification1
- Pain1
- Scar Tissue1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Extraskeletal ossification; Pain; Scar Tissue; Unspecified Infection
MAUDE report 9608250 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121874. One submission often covers many models, so check the product and lot details in each record.
- Z-0007-2023 · Aug 25, 2022 · Open, ClassifiedG7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
- Z-1837-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
- Z-1838-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Other Hip, semi-constrained, cemented, metal/polymer + additive, cemented devices
- G7® Acetabular System 010000664Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented20 reports
- G7 ACETABULAR SCREW 010000999Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented19 reports
- G7® Acetabular System 110010245Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented19 reports
- G7 Acetabular Liner 010000850Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented15 reports
- G7® Acetabular System 010000661Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented13 reports
- G7® Acetabular System 110010242Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented13 reports
- G7 Acetabular Liner 010000937Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented1 death12 reports
- G7 OSSEOTI ACETABULAR SHELL 110010243Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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