Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1041-2014·Announced 2014-02-26

Zimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues

Zimmer, Inc. is recalling 7,044,680 self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, but the source text explicitly states that seal integrity testing met acceptance criteria and no illnesses or injuries are reported. This fits the rubric for a voluntary precautionary recall with low-risk contamination concerns.

Plain-English summary

Zimmer, Inc. is recalling approximately 7,044,680 units of self-tapping cortical screws and cancellous screws. 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 various sizes of 2.7 mm and 4.0 mm screws.

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 indicated that the packaging tray configurations met the acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired manufacturing lots from this specific packaging operation as a precaution.

The affected products were distributed nationwide in the United States and in numerous international locations, including Belgium, Canada, China, France, Germany, India, Japan, and the United Kingdom. Healthcare providers and patients should contact Zimmer, Inc. for further information regarding the recall and potential replacement of the devices.

The recalled product

Product: 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Screws
Hazard: sterility-compromise
packaging-defect
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 →

Same manufacturer · Zimmer, Inc.

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