Agency classClass IIOur severity:High FDA (Devices)·Z-1134-2015·Announced 2015-03-04

Zimmer Biolog Delta Ceramic Femoral Head Recall for Sterile Tray Compromise

Zimmer GmbH is recalling 10,340 BIOLOX delta Ceramic Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection.

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-harm product (periprosthetic infection) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Zimmer GmbH is recalling 10,340 units of the BIOLOX delta Ceramic Femoral Head, a medical device used in total hip arthroplasty. The recall is due to a potential compromise of the inner sterile tray. The affected products were distributed domestically across 42 US 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. The source text does not report any specific illnesses or injuries associated with this recall.

Healthcare providers and patients should check their inventory and patient records for the specific item numbers and lot numbers listed in the recall notice. If a compromised tray is detected, surgery may be delayed. Patients who have already received the device should contact their healthcare provider for guidance.

The recalled product

Product: Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the…
Manufacturer: Zimmer Gmbh
Category: Medical Device — Orthopedic Implant
Hazard: infection
sterile-barrier-compromise
Affected units: 10,340

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 (20)

Item numbers: 00-8775-028-01
00-8775-028-02
00-8775-028-03
00-8775-032-01
00-8775-032-02
00-8775-032-03
00-8775-032-04
00-8775-036-01
00-8775-036-02
00-8775-036-03
00-8775-036-04
00-8775-040-01
00-8775-040-02
00-8775-040-03
00-8775-040-04. Lot #'s: 2524205
2527529
2531817
2543976
2547030
2522713

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

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Same hazard · infection