Zimmer Manufacturing Recalls Mini Magna-FX Cann Screws Due to Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 3,190 units of Mini Magna-FX Cann Screws because of insufficient sealer calibration data for products packaged between August 2010 and April 2013.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 temporary or medically reversible adverse health consequence. The hazard is related to packaging calibration data rather than a direct structural defect or reported injury, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 3,190 units of Mini Magna-FX Cann Screws, which are metallic bone fixation fasteners intended for implantation. The recall covers products under product code HWC with various item numbers, distributed nationwide in the United States.
The recall was initiated due to insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile. The source text does not specify reported illnesses or injuries associated with this recall.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to the recall instructions.
The recalled product
- Product
- Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 3,190
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 72 products in this recall →Related recalls
Same manufacturer · Zimmer Manufacturing B.V.
See all →- HighZimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-05-25
- HighZimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws
FDA (Devices) · 2016-05-25
- HighZimmer VersaFx Femoral Fixation System Screws Recalled for Sterility Concerns
FDA (Devices) · 2016-05-25
- HighZimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns
FDA (Devices) · 2016-05-25
- ModerateZimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect
FDA (Devices) · 2016-05-25
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateZimmer Recalls Magna-Fx Cannulated Screws Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Manufacturing Recalls Mini MagnaFx Cannulated Bone Screws
FDA (Devices) · 2016-05-25
- ModerateZimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failures
FDA (Devices) · 2014-08-27
- HighZimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failure
FDA (Devices) · 2014-08-27
- ModerateZimmer Recalls Trauma Large Screws Due to Packaging Design Failures
FDA (Devices) · 2014-09-03
- ModerateZimmer Recalls Knee Instrument Fixation Screws Due to Packaging Failures
FDA (Devices) · 2014-09-03