The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0073-2014·Announced 2013-11-06

Zimmer Recalls NexGen Femoral Components Due to Packaging Adhesion

Zimmer, Inc. is recalling NexGen femoral components because the packaging bags adhere to the device surfaces.

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 describes a packaging defect (bag adhesion) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling NexGen femoral components, including various CR-FLEX and LPS-FLEX models, due to a packaging defect. The low density polyethylene (LDPE) bags used to package these implants adhere to the highly polished surface of the devices.

The recall involves 604,064 units distributed worldwide, including the United States and numerous international markets. The affected part numbers range from 005750 to 5996-011/018-01/92.

Consumers and healthcare providers should contact Zimmer, Inc. for instructions on how to handle the affected devices.

The recalled product

Product
NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF…
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
604,064

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 (15)

  • Part Number Range: 005750
  • 5764
  • 5950
  • 5952
  • 5956
  • 5960
  • 5962
  • 5964
  • 5966
  • 5970
  • 5972
  • 5990
  • 5992
  • 5994
  • and 5996-011/018-01/92.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

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