Agency classClass IIOur severity:High FDA (Devices)·Z-2033-2014·Announced 2014-07-16

Zimmer M/L Taper Hip Stem Recall Due to Black Residue

Zimmer, Inc. is recalling M/L Taper Hip Stems because black residue was observed in the sterile pouches. The recall covers 1,487 units distributed worldwide.

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 the presence of black residue in a sterile implant pouch represents a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling the M/L Taper Hip Stem Standard & Extended Offset, a femoral stem component of a modular hip joint prosthesis system. The recall is being conducted because black residue was observed in the sterile pouches of the affected devices.

The recall involves 1,487 units of the hip stem, available in various sizes including 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0, and 22.5. The affected products were distributed worldwide, including in the United States, Australia, Canada, China, Europe, India, Japan, Korea, and Singapore.

Patients who have had these hip stems implanted should contact their healthcare provider for further evaluation and guidance. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: contamination
sterility-compromise
Affected units: 1,487

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)

Product ID: 00771100500
Lot #: 60418073
60814878
61085493
61221743
61576204
61621459
61621460
61801966
61825644
61825646
61851938
61856660
61899990
61909935
61957246
61963045
61967714
61978787
62004470

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Zimmer, Inc. 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 3 products in this recall →

Same manufacturer · Zimmer, Inc.

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