Agency classClass IIOur severity:High FDA (Devices)·Z-1136-2015·Announced 2015-03-04

Zimmer Metasul Femoral Head Recalled for Potential Sterile Tray Compromise

Zimmer GmbH is recalling 16 Metasul Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.

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 involves a risk of periprosthetic infection, a significant health hazard, but the source text describes the risk as 'possible' and does not report any actual illnesses or injuries, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer GmbH is recalling 16 units of the Metasul Femoral Head, a medical device indicated for total hip arthroplasty for the treatment of non-inflammatory degenerative joint disease. The recall is due to a potential compromise of the inner sterile tray.

The affected units are identified by item number 734028800 and lot number 61487614. These devices were distributed domestically to 45 states and internationally to Canada and Japan. If a compromised tray is detected, it may result in a delay in surgery. If an undetected breach occurs in both the inner and outer trays and contamination is present, a periprosthetic infection is possible, which could lead to revision surgery.

Healthcare providers and facilities should check their inventory for the specific item and lot numbers listed above. If the product is found, it should be quarantined and not used until further notice.

The recalled product

Product: Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.
Manufacturer: Zimmer Gmbh
Category: Medical Device — Orthopedic Implant
Hazard: infection
sterility-compromise
Affected units: 16

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 (1)

Item numbers: 734028800 Lot #'s: 61487614

Distribution

Distributed in 45 states:

Part of a larger recall action

This product is one of 5 recalled by Zimmer Gmbh 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 5 products in this recall →

Same manufacturer · Zimmer Gmbh

See all →

High
Biolox Taper Sleeve Mislabeling: Wrong Component Size in Hip Replacement
FDA (Devices) · 2024-09-18
Moderate
Zimmer GmbH Recalls Mislabeled Biolox Option Taper Sleeve for Hip Replacement
FDA (Devices) · 2024-09-18
High
Zimmer Femoral Nail Recall: Risk of Commingled Angle Versions
FDA (Devices) · 2021-06-09
High
Zimmer Natural Nail cephalomedullary device angle mismatch recall
FDA (Devices) · 2021-06-09
Moderate
Zimmer Sidus Stem-Free Shoulder Humeral Head Recall for Incorrect Labeling
FDA (Devices) · 2019-10-09

Same hazard · infection