Zimmer Recalls Sterile Orthopedic Screws Due to Packaging Validation Issues
Zimmer is recalling specific sterile orthopedic screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
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: This is a voluntary precautionary recall (FDA Class II) where the product passed seal integrity testing, and no illnesses or injuries are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling approximately 7,044,680 units of sterile orthopedic lag screws. The affected products include various sizes of 12.7mm and 15.8mm diameter screws, identified by item codes starting with 001930. These devices were sterile packaged in the Building 1 packaging operations at Zimmer Manufacturing B.V. in Ponce, Puerto Rico.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations at the specified facility were not properly validated. Although subsequent seal integrity testing showed that the packaging trays met the acceptance criteria for sterile barrier integrity (99% reliability with a 90% confidence interval), Zimmer decided to recall all non-expired manufacturing lots from this specific packaging line as a precautionary measure.
The affected products were distributed worldwide, including in the United States and numerous international markets. Healthcare providers and patients should check their inventory and patient records for these specific item codes. If you have used or possess these devices, contact Zimmer or your healthcare provider for further instructions.
The recalled product
- Product
- Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
- Manufacturer
- Zimmer, Inc.
- Affected units
- 7,044,680
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 44 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 44 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 · 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