The Recall Desk
ModerateFDA (Devices)·Z-1052-2018·Announced 2018-03-21

Zimmer Biomet Recalls Patello-Femoral Joint Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 patello-femoral joint implants because LDPE bag packaging may leave residue on the highly polished implant surfaces.

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: The recall is classified as FDA Class II, and the hazard involves packaging residue on a medical device without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of the Patello-Femoral Joint System Gender Solutions Patello-Femoral implants. These medical devices are indicated for the treatment of osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

The recall was initiated because the LDPE bag packaging for these highly polished implants may adhere to the implant surface. This adhesion can leave residue or material from the LDPE bag on the implant after it is removed from the packaging.

The affected units were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and the UAE. The specific catalog numbers affected are 00-5926-011-01, 00-5926-012-01, 00-5926-013-01, 00-5926-013-02, 00-5926-014-02, and 00-5926-015-02.

The recalled product

Product
PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
13,227

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 (13)

  • 00-5926-011-01 Knee PFJ FEM
  • CEMENTED
  • SZ 1
  • LEFT 00-5926-012-01 Knee PFJ FEM
  • SZ 2
  • LEFT 00-5926-013-01 Knee PFJ FEM
  • SZ 3
  • LEFT 00-5926-013-02 Knee PFJ FEM
  • RIGHT 00-5926-014-02 Knee PFJ FEM
  • SZ 4
  • RIGHT 00-5926-015-02 Knee PFJ FEM
  • SZ 5
  • RIGHT

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 48 recalled by Zimmer Biomet, 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 48 products in this recall →

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