The Recall Desk
HighFDA (Devices)·Z-2348-2021·Announced 2021-09-01

Orthopedic knee replacement stem: wrong size provided in mislabeled packaging

DePuy Orthopaedics recalled 7 units of ATTUNE REVISION CEMENTED STEM (16×80mm) because packages labeled as 16×80mm contained 16×130mm stems instead. This size mismatch could cause improper implantation if not caught before surgery.

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: FDA Class II recall involving a packaging error that resulted in wrong-sized orthopedic implants being distributed. No injuries have been reported, but incorrect implantation could cause serious complications, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

DePuy Orthopaedics, Inc. recalled 7 units of ATTUNE REVISION CEMENTED STEM 16×80mm (Part Number: 1512-16-080, Lot J82N61) intended for total knee replacement surgery. The affected lot was distributed to Canada and France.

The defect: packages labeled as containing a 16×80mm stem actually contained a 16×130mm stem instead. This discrepancy means the wrong-sized component was shipped with incorrect packaging labeling.

The hazard: if the larger, incorrect stem were implanted without being caught, it could result in improper fit within the patient's knee joint, potentially requiring revision surgery or other clinical intervention.

Healthcare providers and patients who received this lot should verify the actual stem size matches the surgical plan before implantation. DePuy Orthopaedics will provide replacement correct-sized stems.

The recalled product

Product
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant / Joint Prosthetic
Hazard
  • packaging-error
  • sizing-mismatch
  • wrong-component-supplied

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 Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010

Distribution

Distribution scope not specified by the agency.

Related recalls

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