CLASS II ONGOING Device recall · Reported 9 Oct 2024 · FDA Enforcement Report
Stryker Tornier Perform Humeral System, Reversed Insert recalled
Tornier is recalling Stryker Tornier Perform Humeral System, Reversed Insert, 45%, distributed nationwide in the US. The recall was initiated on 29 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3309-2024
- FDA event ID
- 95245
- Recalling firm
- Tornier, Bloomington, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Aug 2024
- FDA classified
- 27 Sep 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 29 Aug 2024 | Recall initiated by company | |
| 27 Sep 2024 | Classified by FDA | +29 days |
| 9 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
Product as listed by the FDA
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
Which lots are affected?
GTIN 00846832084494, Batch Lot # 1495AY
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tornier
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HRS Max parts: Tornier HRS Max Tuberosity Body Lat Coat, Small recalled | Tornier | Labeling Errors | Nationwide |
| Device | CLASS II | Perform Reversed Perip Screw 5.0mmx18mm Non Sterile recalled by Tornier | Tornier | Labeling Errors | Nationwide |
| Device | CLASS II | stryker Latitude EV Humeral Revision Stem Trial, L:, Size recalled | Tornier | Other | MN |
| Device | CLASS II | stryker Tornier Perform Humeral System recalled | Tornier | Other | Nationwide |
| Device | CLASS II | Stryker Tornier Perform Reversed Glenoid Press-Fit Short recalled | Tornier | Packaging Defects | 9 states |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |