Zimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise
Zimmer Manufacturing B.V. is recalling specific lots of 3.5 mm Cortical Screws because a small hole may be present in the inner tray, potentially compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential sterility compromise in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific lots of Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping. The affected products include screws of various lengths (10 mm, 14 mm, 16 mm, 24 mm, 30 mm, 40 mm, and 75 mm) with specific catalog numbers. The recall involves 794 units distributed worldwide, including the United States, Korea, Japan, and numerous other countries.
The recall is being conducted because a small hole may be present in the inner tray of the sterile packaging for these specific lots. This defect could potentially compromise the sterile barrier of the implant. The affected lot numbers are 63252354, 63283819, 63308551, 63252355, 63312340, 63252350, 63283820, and 63243831.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Patients who have received these implants should contact their healthcare provider for guidance.
The recalled product
- Product
- Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 794
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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 12 products in this recall →Related recalls
Same manufacturer · Zimmer Manufacturing B.V.
See all →- ModerateZimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect
FDA (Devices) · 2016-05-25
- ModerateZimmer 2.7 mm Cortical Screws Recalled for Potential Tray Hole
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
- HighZimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws
FDA (Devices) · 2016-05-25
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12