Skip to content

Prime SeriesRecalls & reported problems across all models

Stryker Corporation · 21 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name at least one Prime Series model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
1,548
Deaths reported
2
Injuries reported
47
Recalls
2

We found 21 models of Prime Series by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 1,548 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2018 and May 18, 2026 — classified as 2 deaths, 47 injuries, 1,499 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (357 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 65 reportsFeb 2024: 1 reportsMar 2024: 2 reportsApr 2024: 58 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 64 reportsAug 2024: 1 reportsSep 2024: 1 reportsOct 2024: 62 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 60 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 60 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 12 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 49 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 25 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 22 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202665
Last 36 months. The most recent month may be incomplete.

Prime Series recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. May 12, 2021Open, Classified

    Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

    Z-2208-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. May 12, 2021Open, Classified

    Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

    Z-2207-2021 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported Prime Series problems

Device problems

  • Mechanical Jam357
  • Electrical /Electronic Property Problem189
  • Fluid/Blood Leak166
  • Grounding Malfunction140
  • Mechanical Problem124
  • Intermittent Loss of Power114
  • Unintended System Motion112
  • Sharp Edges97

Patient problems

  • No Clinical Signs, Symptoms or Conditions1,122
  • No Patient Involvement330
  • Pain32
  • Insufficient Information28
  • No Consequences Or Impact To Patient22
  • Fall20
  • Laceration(s)13
  • Muscle/Tendon Damage11

Prime Series models

21 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Prime Series adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Stryker Corporation products

All Stryker Corporation devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page