PHOENIX RETROGRADE NAIL SYSTEM 14-444230Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 18, 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 00888480166627), received between Jun 11, 2025 and Jun 11, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
8 other recalls cover devices cleared under the same FDA submission (K072161); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 22186344 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K072161. One submission often covers many models, so check the product and lot details in each record.
- Z-2278-2009 · Apr 2, 2009 · TerminatedTI Cann Partl Thd Recon Screw 6.00MM x 70MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
- Z-2283-2009 · Apr 2, 2009 · TerminatedTI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
- Z-2277-2009 · Apr 2, 2009 · TerminatedTI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
- Z-2279-2009 · Apr 2, 2009 · TerminatedTI Cann Partl Thd Recon Screw 6.00MM x 75MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
- Z-2281-2009 · Apr 2, 2009 · TerminatedTI Cann Partl Thd Recon Screw 6.00MM x 85MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
- Z-2282-2009 · Apr 2, 2009 · TerminatedTI Cann Partl Thd Recon Screw 6.00MM x 90MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
- Z-2280-2009 · Apr 2, 2009 · TerminatedTI Cann Partl Thd Recon Screw 6.00MM x 80MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
- Z-2115-2009 · Mar 27, 2009 · TerminatedPhoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation Systems; Rx only Biomet Trauma, 100 Interpace Parkway, Parsippany, NJ 077054 Intended to aid in the a
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
- NA 03.033.001Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES265 reports
- GAMMA 3125-1180SStryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES249 reports
- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page