Novation 140-32-52Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Novation (184)
Data updated Oct 16, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862537270), received between Dec 27, 2023 and Aug 28, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls cover devices cleared under the same FDA submission (K173583); 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.
Reports received per month
Recalls naming this device
- Dec 31, 2024Open, Classified
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Z-1166-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information2
- Joint Dislocation1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THA (TOTAL HIP ARTHROPLASTY). SUBSEQUENTLY, THE PATIENT EXPERIENCED AN INFECTION RESULTING IN A REVISION OF THE HEAD AND LINER. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 22913327 ↗InjuryDec 27, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT, INITIAL HIP IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2023. THE INLAY WAS REPLACED WITH A 142-36-62 CC INLAY VITAMIN E, LIPPE, Ø 36, GR. 2. NO FURTHER INFORMATION KNOWN AT THIS TIME.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 18401562 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K173583. One submission often covers many models, so check the product and lot details in each record.
- Z-1165-2025 · Dec 31, 2024 · Open, ClassifiedAcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 LNR G 32MM 140-32-28 AM EHXL 0 LNR H 32MM 140-28-29 AM EHXL 0 LNR J 28MM 140-32-2
- Z-0577-2024 · Nov 21, 2023 · Open, ClassifiedAcuMatch Hip System, Catalog Number 142-32-27
Other Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented devices
- AcuMatch 142-32-27Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2 recalls0 reports
- Novation 140-36-52Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall8 reports
- G7 DEPTH GAUGE 110010717Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented54 reports
- Novation 142-32-61Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall1 report
- Novation 140-36-54Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall1 report
- Novation 142-32-51Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 142-40-64Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 146-32-53Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 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 16, 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