Stryker Recalls 6.5mm Cancellous Bone Screws Due to Packaging Mix-Up
Stryker Howmedica Osteonics is recalling approximately 72 units of 6.5mm Cancellous Bone Screws because packaging may contain the wrong screw length.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a packaging mix-up (wrong length screw) without reporting any injuries, illnesses, or deaths. This aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where harm has not yet been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling approximately 72 units of Torx 6.5mm Cancellous Bone Screws (Catalog No. 2030-6525-1). The affected lots are MLHYL7 and MLJT50. These screws 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 Stryker received field reports indicating that certain lots 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 United Kingdom. Healthcare providers and facilities that have received these specific lots should stop using them and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 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…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 72
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 (2)
- Catalog No: 2030-6525-1 Lot Code: MLHYL7
- MLJT50 Ref 2030-6525-1
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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