Stryker Recalls 6.5mm Cancellous Bone Screws Due to Packaging Mix-Up
Stryker is recalling 6.5mm Cancellous Bone Screws because packaging may contain the wrong screw length, potentially leading to incorrect surgical fixation.
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 (medical device) where a packaging error could lead to incorrect surgical fixation, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling approximately 358 units of 6.5mm Cancellous Bone Screws (Ref 2030-6535-1). These medical devices are used in total hip arthroplasty (THA) to provide initial cup fixation and help prevent spin-out of the cup.
The recall was initiated after field reports indicated that certain lots of the screws are associated with a product mix-up. Specifically, packaging labeled for a 35 mm screw may contain a 25 mm screw, and packaging labeled for a 25 mm screw may contain a 35 mm screw. This discrepancy could result in the use of an incorrect screw length during surgery.
The affected products were distributed worldwide, including in the United States, Canada, Belgium, Finland, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Portugal, Spain, Turkey, and the UK. Healthcare providers should stop using the affected lots and contact Stryker for further instructions.
The recalled product
- Product
- Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 358
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 (10)
- Catalog No: 2030-6535-1 Lot Code: MLDNAV
- MLDXV2
- MLH11M
- MLH17R
- MLH3K8
- MLH4L6
- MLH7RV
- MLHK1X
- MLHL99
- MLJDJT Ref 2030-6535-1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Stryker Howmedica Osteonics Corp. 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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