Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1109-2016·Announced 2016-03-23

Zimmer Manufacturing Recalls Hip Arthroplasty Femoral Heads Due to Sealer Calibration

Zimmer Manufacturing B.V. is recalling 366 units of 6 Degree COCR Femoral Heads used in hip arthroplasty due to insufficient sealer calibration data.

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 explicitly states no illnesses or injuries are reported and the hazard is related to calibration data rather than a confirmed defect causing harm, fitting the criteria for a moderate voluntary precautionary recall.

Plain-English summary

Zimmer Manufacturing B.V. is recalling 366 units of 6 Degree COCR 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 including 902602500, 902602600, 902602700, 902602800, 902602900, 902603000, 902603300, and 902603200. The distribution pattern is listed as US Nationwide Distribution. Specific lot numbers associated with this recall include 61603870, 60973105N, 60892289N, 60900891N, 62279763, 62093449, 62185961, 62279764, 62384218, 62082438, 62268537, and 62384219.

Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions regarding the return or replacement of these devices. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product: Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COCR FEM HEAD 26 902602800 6 DEGREE COCR FEM HEAD 28 902602900 6 DEGREE COCR FEM HEAD 28…
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implants
Hazard: sterility-compromise
calibration-error
Affected units: 366

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 →

High
Zimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise
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