The Recall Desk
HighFDA (Devices)·Z-0621-2021·Announced 2020-12-23

Biomet Custom Cancellous Thread Recalled for Potential Sterile Seal Breach

Biomet is recalling specific lots of Custom Cancellous Thread devices because a breach in the sterile seal could lead to loss of sterility.

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 potential loss of sterility in implanted medical devices, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet, Inc. is recalling specific lots of Custom Cancellous Thread medical devices. The recall involves item numbers CP161941 and CP161943, with lot numbers 534760, 534800, and 427670. A total of 7,428 units are affected by this action.

The reason for the recall is that specific lots of these sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to a loss of sterility of the device. These devices are used for various orthopedic conditions, including noninflammatory degenerative joint disease, rheumatoid arthritis, and correction of functional deformity.

The affected products were distributed worldwide, including in the United States, Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, EMEA, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, and Taiwan. Healthcare providers and patients should check their inventory and records for the specific lot numbers listed above. If a device is found to be from an affected lot, it should not be used, and Biomet should be contacted for further instructions.

The recalled product

Product
Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fract
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
7,428

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)

  • Lot numbers 534760 534800 427670

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 16 recalled by Biomet, 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 16 products in this recall →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · loss of sterility

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