Zimmer Recalls 4.5 mm Malleolar Screws Due to Leak Test Failures
Zimmer, Inc. is recalling 47,682 units of 4.5 mm Malleolar Screws because they failed a leak test due to inner cavity damage.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer, Inc. is recalling 47,682 units of 4.5 mm Malleolar Screws. The recall is being conducted because the devices failed a leak test due to damage of the inner cavity only.
The affected products are sterile trauma screws with Item Numbers 47-4845-025, 030, 035, 040, 050, 055, 060, 065, and 070. The recall number is Z-2250-2014.
The products were distributed nationally across the United States and internationally to countries including Canada, Mexico, Argentina, Australia, and others. Healthcare providers and facilities should stop using these specific units and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- 4.5 mm Malleolar Screw Sterile zimmer
- Manufacturer
- Zimmer, Inc.
- Affected units
- 47,682
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 (10)
- Item Number 47-4845-025
- 030
- 035
- 040
- 050
- 055
- 060
- 065
- 070
- -08
Distribution
Part of a larger recall action
This product is one of 8 recalled by Zimmer, Inc. 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 8 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- ModerateZimmer Shoulder System Reamer Guide recalled for plastic breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
Same hazard · leak test failure
See all →- HighMED-EL SONATAti100 Cochlear Implant Recall for Leak Test Failures
FDA (Devices) · 2019-08-14
- HighMED-EL PULSARci100 Cochlear Implant Recalled for Leak Test Failures
FDA (Devices) · 2019-08-14
- HighAmbu Universal Flex2 Breathing Circuits Recalled for Leak Test Failures
FDA (Devices) · 2018-01-17
- ModerateCypress Medical Recalls McKesson Vinyl Exam Gloves for Leak Test Failure
FDA (Devices) · 2016-12-21
- ModerateZimmer Recalls 6.5 mm Cancellous Screws Due to Leak Test Failures
FDA (Devices) · 2014-08-27