Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1010-2014·Announced 2014-02-26

Zimmer Recalls Interlocking IM Screws Due to Packaging Validation Issues

Zimmer is recalling Interlocking IM Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

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. The hazard is theoretical because the product passed seal integrity testing, and no illnesses or injuries are reported in the source text, fitting the criteria for a voluntary precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling Interlocking IM Screw 4.5 and Interlocking IM Screw LG products. The recall affects 7,044,680 units that were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The products were distributed nationwide in the United States and in numerous countries worldwide, including Belgium, Canada, China, France, Germany, India, Italy, Japan, and the United Kingdom.

The recall was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations in Building 1 were not properly validated. To assess the risk, Zimmer conducted seal integrity testing to evaluate if the previously packaged product met established requirements for sterile barrier integrity. The acceptance criteria for this testing was 99% reliability with a 90% confidence interval. The testing showed that the packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays.

Despite the positive test results, Zimmer has decided to recall all manufacturing lots that have not expired and were sterile packaged in the affected facility. The recall includes specific product codes starting with 0022530 and a long list of specific catalog numbers provided in the agency's structured data. Consumers and healthcare providers should check their inventory for these specific product codes and contact Zimmer for further instructions.

The recalled product

Product: INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implants
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 →

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