Agency classClass IIOur severity:High FDA (Devices)·Z-1133-2015·Announced 2015-03-04

Zimmer Metasul Femoral Head Recalled for Potential Sterile Tray Compromise

Zimmer GmbH is recalling 30 Metasul Femoral Head units 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 is classified as FDA Class II and involves a risk of periprosthetic infection, which is a significant health hazard, but the source text does not report any confirmed illnesses or injuries, placing it in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer GmbH is recalling 30 units of the Metasul Femoral Head, a modular head component used in total hip arthroplasty. The recall is due to a potential compromise of the inner sterile tray. The affected units are identified by item numbers 19.32.05, 19.32.06, and 19.32.08, and lot numbers 2560585, 2553420, 2556039, 2560586, and 2563398.

The hazard associated with this recall is that 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 a revision surgery. The agency has classified this recall as Class II.

The affected products were distributed domestically to numerous states including AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, as well as internationally to Canada and Japan. Healthcare facilities and distributors should check their inventory for the specific item and lot numbers listed and contact the recalling firm for instructions on how to proceed.

The recalled product

Product: Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
Manufacturer: Zimmer Gmbh
Category: Medical Device — Orthopedic Implant
Hazard: infection
sterility-compromise
Affected units: 30

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 (8)

Item numbers: 19.32.05
19.32.06
19.32.08
Lot #'s: 2560585
2553420
2556039
2560586
2563398

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 →

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