Agency classClass IIOur severity:High FDA (Devices)·Z-1026-2014·Announced 2014-02-26

Zimmer Recalls HGP II Acetabular Cup Due to Packaging Validation Issues

Zimmer is recalling HGP II Acetabular Cup Mod units because packaging operations at a Puerto Rico facility were not properly validated, despite passing 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where sterile barrier integrity was questioned due to unvalidated packaging processes. While seal integrity testing met acceptance criteria, the potential risk of compromised sterility in an implantable device constitutes a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Zimmer, Inc. is recalling HGP II Acetabular Cup Mod units. The recall affects 7,044,680 total units that were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The product was 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. Although subsequent seal integrity testing showed that the packaging tray configurations met the acceptance criteria for sterile barrier integrity with 99% reliability and a 90% confidence interval, Zimmer decided to recall all non-expired manufacturing lots from this specific facility and operation.

Healthcare providers and patients should check their inventory and patient records for HGP II Acetabular Cup Mod units with the following codes: 60035657, 60035663, 60163301, 60078959, and 60163345. Affected units should be removed from use and returned to Zimmer, Inc. for further instructions.

The recalled product

Product: HGP II ACETABULAR CUP MOD
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: sterility-compromise
packaging-defect
Affected units: 7,044,680

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

60035657 60035663 60163301 60078959 60163345

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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