CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report
Orthopedic manual surgical instrument Usage recalled
Stryker Howmedica Osteonics is recalling Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument, distributed nationwide in the US. The recall was initiated on 1 Jul 2016 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-2396-2016
- FDA event ID
- 74743
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2016
- FDA classified
- 11 Aug 2016
- Reported
- 17 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 1 Jul 2016 | Recall initiated by company | |
| 11 Aug 2016 | Classified by FDA | +41 days |
| 17 Aug 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Why was it recalled?
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Which lots are affected?
Catalog No. 0930-9-003
Where was it sold?
Worldwide Distribution - US Nationwide
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 Stryker Howmedica Osteonics
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hoffmann LRF Safety Clip (Bone Transport Strut) recalled | Stryker Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Reunion TSA Peg Alignment Sound recalled by Stryker Howmedica Osteonics | Stryker Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R recalled | Stryker Howmedica Osteonics | Sterility | Nationwide |
| Device | CLASS II | LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile recalled | Stryker Howmedica Osteonics | Device Malfunction | Nationwide |
| Device | CLASS II | Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor recalled | Stryker Howmedica Osteonics | Other | NJ |
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 |