Zimmer Hip Joint Prosthesis Recalled for Black Residue in Sterile Pouches
Zimmer, Inc. is recalling 852 units of M/L Taper Reduced Neck hip joint prostheses because black residue was observed in the sterile pouches.
What this means for you
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 (implanted medical device) where the presence of residue in sterile packaging implies a potential breach of sterility, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer, Inc. is recalling 852 units of the M/L Taper Reduced Neck Standard & Extended Offset Hip Joint Prosthesis. The recall covers specific sizes (4, 5, 6, 7.5, 9, 10, 11, and 12.5) and multiple lot numbers associated with various product IDs. The product is the femoral stem component of a modular hip replacement system.
The recall was initiated because black residue was observed in the sterile pouches containing the M/L Taper and Kinectiv stems. This observation raises concerns regarding the sterility and integrity of the packaging for these medical devices.
The affected units were distributed worldwide, including the United States, Australia, Canada, China, Europe, India, Japan, Korea, and Singapore. Patients who have had these specific hip joint prostheses implanted should contact their healthcare provider for guidance on whether further evaluation or action is necessary.
The recalled product
- Product
- Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary fo
- Manufacturer
- Zimmer, Inc.
- Affected units
- 852
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: 00771100410
- Lot #: 60876583
- 61098988
- 61158127
- 61230791
- 61542496
- 61548105
- 61702995
- 61729254
- 61904645
- 61957233
- 61963047
- 61998392
- 62004467
- 62067479
- 62078278
- 62096889
- 62107667
- 62145541
- 62153634
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.
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