Zimmer Recalls Orthopedic Screws Due to Packaging Validation Deficiencies
Zimmer is recalling 7,044,680 orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
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 for a medical device where the agency classification is Class II, but the source text explicitly states that seal integrity testing met acceptance criteria and no illnesses or injuries are reported.
Plain-English summary
Zimmer, Inc. is recalling approximately 7,044,680 units of various orthopedic screws, including periosteal and cancellous screws in 3.5mm and 4.0mm diameters. The affected products were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The recall includes all manufacturing lots that have not expired and were processed in this specific facility.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing indicated that the packaging trays met acceptance criteria for sterile barrier integrity, Zimmer decided to recall the products as a precautionary measure to ensure patient safety.
The affected products were distributed worldwide, including in the United States and numerous international markets such as Canada, the United Kingdom, Germany, and Japan. Healthcare providers and patients should check their inventory and records for these specific product codes and contact Zimmer for further instructions regarding the recall.
The recalled product
- Product
- PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM CORT
- 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.
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