BIOSTOP 5463-18-000Recalls & reported problems
Depuy Orthopaedics, Inc. · BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 18 · Class 2 · Implant
All models of BIOSTOP (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295174592), received between Aug 30, 2019 and Aug 30, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Recalls naming this device
- Dec 19, 2022Class IIOpen, Classified
All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.
Z-0951-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2019Fracture; Fracture
WE HAD A TOTAL HIP REPLACEMENT (THR) AND IT WAS COMPLICATED AT THE MOMENT OF ADDING THE FINAL PIECE, THE IMPACTOR BROKE. THE SCREWS WERE TRIED TO BE PLACED BUT IT DID NOT HAVE A GOOD GRIP BECAUSE THE PATIENT HAD OSTEOPOROSIS. AND FOR THAT REASON THEY CEMENTED THE LINERS. AND WHEN HE WAS PLACING THE BIOSTOP 18 IT BROKE OFF AND COULD NOT PLACE IT AND PLACED ANOTHER MEASURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8949493 ↗
Other CEMENT OBTURATOR devices
- BIOSTOP 5463-12-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall6 reports
- BIOSTOP 5463-08-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-16-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall1 report
- BIOSTOP 5463-20-000Depuy Orthopaedics, Inc. · CEMENT OBTURATOR1 recall0 reports
- NA 0306703000Stryker Corporation · CEMENT OBTURATOR1 recall0 reports
- ACM BioPrep 0306705000Stryker Corporation · CEMENT OBTURATOR1 recall0 reports
- PREP-IM 121010Smith & Nephew, Inc. · CEMENT OBTURATOR10 reports
- CEMENT RESTRICTOR EBO102Tornier · CEMENT OBTURATOR8 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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