Zimmer Recalls Compression Screws Due to Packaging Validation Review
Zimmer is recalling 7,044,680 compression screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent 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 initiated by the manufacturer after a validation review, with no reported illnesses or injuries and subsequent testing confirming the products met sterile barrier integrity criteria.
Plain-English summary
Zimmer, Inc. is recalling approximately 7,044,680 units of compression screws in various sizes (1/2, 1-1/2, 1-1/4, 1-3/4, 1, 2, 3/4 inches). The recall covers all manufacturing lots that have not expired and were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations in Building 1 were not properly validated. Although Zimmer conducted seal integrity testing and the packaging tray configurations met the acceptance criteria for sterile barrier integrity (99% reliability with a 90% confidence interval), the company decided to recall the affected lots as a precautionary measure.
The affected products were distributed worldwide, including in the United States and numerous international markets such as Belgium, Canada, China, France, Germany, India, Japan, and the United Kingdom. Healthcare providers and patients should check their inventory and patient records for these specific lot codes and contact Zimmer for further instructions.
The recalled product
- Product
- COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
- 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 · packaging validation
See all →- ModerateZimmer Recalls One-Piece Lag Screws Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Recalls Hip Prostheses Due to Unvalidated Packaging Operations
FDA (Devices) · 2014-02-26
- ModerateZimmer Recalls Free-Lock Orthopedic Devices Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Recalls Versys Heritage Femoral Stems Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Recalls CPT 12/14 COCR Medical Devices Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26