Stryker Recalls Asnis III Cannulated Screws Due to Incorrect Length
Stryker is recalling 23 units of Asnis III Cannulated Screws because the length of the device was reported to be incorrect.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The defect is a dimensional inaccuracy (incorrect length) rather than a contamination or structural failure leading to immediate severe injury, fitting the Moderate severity criteria for a voluntary precautionary recall of a medical device.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 23 units of Asnis III Cannulated Screws. The recall involves two specific reference numbers: 604640 (4.0x40mm) and 604642S (4.0x42mm, sterile). These medical devices are intended for fracture fixation of small and long bones and of the pelvis, but are not intended for spinal use.
The recall was initiated after Stryker received a report that the length of the cannulated screw, specifically article # 604640, was incorrect. The affected units are distributed nationwide in the United States, specifically in the states of Florida, Ohio, Texas, and Virginia.
The recall covers 21 units of Catalog # 604640 with Lot Code R11428 and 1 unit of Catalog # 604642S with Lot Code R09071. Note that the raw source text references Lot R11482 for the reported issue, while the structured data lists Lot R11428; users should verify specific lot numbers against their inventory. Healthcare providers and patients should contact Stryker for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog # 604640
- Lot Code R11428 21 units Catalog # 604642S
- Lot Code R09071 1 unit
Distribution
Related recalls
Same manufacturer · Stryker Howmedica Osteonics Corp.
See all →- HighStryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk
FDA (Devices) · 2017-05-31
- SevereStryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
FDA (Devices) · 2017-01-18
- ModerateStryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
- SevereStryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
- HighStryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
FDA (Devices) · 2016-10-19
Same hazard · dimensional defect
See all →- HighMedline ENFit G-tube connectors may leak from dimensional specification failure
FDA (Devices) · 2026-04-08
- HighMedline ENFit G-tube connector kits may leak from dimensional defect
FDA (Devices) · 2026-04-08
- HighAesculap MINOP trocar shafts may be longer than specified
FDA (Devices) · 2026-03-11
- ModerateMedline Soft Liner Dimensional Variation May Affect Outer Canister Fit
FDA (Devices) · 2024-08-28
- ModerateMedical Device Liner Recalled for Dimensional Variation Affecting Fit
FDA (Devices) · 2024-08-28