The Recall Desk
ModerateFDA (Devices)·Z-1059-2018·Announced 2018-03-21

Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished 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 implants 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 CR-FLEX GSF and GSK Precoat hip and knee implants. The recall affects various sizes (C through G, left and right) distributed worldwide, including the United States and 23 other countries.

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

These devices are indicated for patients with painful or disabling knee joints due to osteoarthritis or traumatic arthritis, previous tibial condyle or plateau fractures, varus or valgus deformities, or revision of previous arthroplasty procedures. The devices are designed for cemented use only. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the affected lots.

The recalled product

Product
CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF PRECOAT SZ D-L¿ CR-FLEX GSF PRECOAT SZ D-R¿ CR-FLEX GSF PRECOAT SZ E-L¿ CR-FLEX GSF PRECOAT SZ E-R¿ CR-FLEX GSF PRECOAT SZ F-L¿ CR-FLEX GSF PRECOAT SZ F-R¿ CR-FLEX GSF PRECOAT SZ G-L¿ CR-FLEX GSK PRECOAT
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
13,227

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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