Agency classClass IIOur severity:High FDA (Devices)·Z-1169-2016·Announced 2016-03-23

Zimmer Versis Press Fit Hip Components Recalled for Sterility Concerns

Zimmer Manufacturing B.V. is recalling 2,388 Versis Press Fit hip arthroplasty components 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, which typically corresponds to a 'High' severity score (3) in the absence of reported hospitalizations or injuries, as the risk is related to potential loss of sterility rather than a confirmed structural defect or reported harm.

Plain-English summary

Zimmer Manufacturing B.V. is recalling 2,388 units of Versis Press Fit LD/FX hip arthroplasty components. These medical devices are used in total or hemi hip arthroplasty procedures. The recall covers specific item numbers 783401000 through 783401600 under product code JDI.

The recall was initiated because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The source text notes that the affected products are sterile, but the lack of calibration data creates a potential risk regarding the integrity of the sterile packaging. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The affected products were distributed nationwide in the United States. Healthcare providers and patients should check their inventory and patient records for the specific lot numbers listed in the official recall notice. If a patient has received one of these devices, they should contact their healthcare provider for guidance on monitoring or potential revision surgery.

The recalled product

Product: Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS FIT LD/FX SZ 783401300 VERSYS PRESS FIT LD/FX SZ 783401400 VERSYS PRESS FIT LD/FX SZ…
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implant
Hazard: sterility-compromise
infection-risk
Affected units: 2,388

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

Same hazard · sterility compromise