Agency classClass IIOur severity:High FDA (Devices)·Z-1101-2016·Announced 2016-03-23

Zimmer Manufacturing Recalls Unipolar Femoral Heads Due to Sterility Concerns

Zimmer Manufacturing B.V. is recalling 2,239 unipolar femoral heads used in hip arthroplasty due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

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 is classified as FDA Class II and involves a risk to the sterility of medical devices, which falls under the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer Manufacturing B.V. is recalling 2,239 units of unipolar femoral heads (product code JDI) used in total or hemi hip arthroplasty. The recall is being conducted because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile.

The recall covers specific item numbers and lot numbers distributed nationwide in the United States. The source text does not specify the exact number of patients affected or report any illnesses or injuries associated with the use of these devices.

Consumers and healthcare providers should contact Zimmer Manufacturing B.V. for further instructions on how to handle the recalled devices. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400…
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implants
Hazard: sterility-compromise
Affected units: 2,239

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 72 recalled by Zimmer Manufacturing B.V. 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 72 products in this recall →

Same manufacturer · Zimmer Manufacturing B.V.

See all →

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FDA (Devices) · 2016-05-25
High
Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws
FDA (Devices) · 2016-05-25
High
Zimmer VersaFx Femoral Fixation System Screws Recalled for Sterility Concerns
FDA (Devices) · 2016-05-25
High
Zimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns
FDA (Devices) · 2016-05-25
Moderate
Zimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect
FDA (Devices) · 2016-05-25

Same hazard · sterility compromise