Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-12-19 | Z-0951-2023 | Class II | Open, 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.Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Latvia, Lebanon, Luxemburg, Mexico, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, and Uruguay. | 2199 US; 43515 OUS | code info di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-03-28 | NAI | No action indicated | DePuy Orthopaedics, Inc. | 0 |
| 2022-05-12 | NAI | No action indicated | DePuy Orthopaedics, Inc. | 0 |
| 2019-11-08 | NAI | No action indicated | DePuy Orthopaedics, Inc. | 0 |
| 2017-09-01 | VAI | Voluntary action indicated | DePuy Orthopaedics, Inc. | 2 |
| 2015-10-01 | VAI | Voluntary action indicated | DePuy Orthopaedics, Inc. | 2 |
| 2015-09-24 | NAI | No action indicated | DePuy Orthopaedics, Inc. | 0 |
| 2012-11-26 | VAI | Voluntary action indicated | DePuy Orthopaedics, Inc. | 6 |
| 2011-12-08 | WL | Warning Letter | DePuy Orthopaedics, Inc. | — |
| 2011-08-16 | NAI | No action indicated | DePuy Orthopaedics, Inc. | 0 |
| 2011-06-07 | OAI | Official action indicated | DePuy Orthopaedics, Inc. | 6 |
| 2010-08-19 | WL | Warning Letter | DePuy Orthopaedics, Inc. | — |
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