NA 47-2348-018-35Recalls & reported problems
Zimmer, Inc. · 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 00889024087699), received between Mar 19, 2022 and Mar 19, 2022 — classified as 1 injury.
4 other recalls cover devices cleared under the same FDA submission (K111447); 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant1
- Hyperresponsive to stimuli1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT ANKLE OPEN REDUCTION INTERNAL FIXATION PROCEDURE. SUBSEQUENTLY SWELLING, PAIN, SENSITIVITY, DISCOLORATION, AND UNABLE TO WEAR SHOES WAS REPORTED WITH PLATE AND ALL SCREWS REMOVED WITH NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Failure of Implant; Hyperresponsive to stimuli; Pain; Swelling/ Edema
MAUDE report 13826354 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K111447. One submission often covers many models, so check the product and lot details in each record.
- Z-1676-2016 · May 4, 2016 · TerminatedPeriarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
- Z-1105-2016 · Jan 11, 2016 · TerminatedProduct 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X 16MM 47234806535 3.5MM CORT SCR
- Z-1154-2016 · Jan 11, 2016 · TerminatedProduct 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SC
- Z-2549-2014 · Jul 22, 2014 · TerminatedTrauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X1
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 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.
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