Z-0388-2013Class II

Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are...

Name: Z-0388-2013 Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2012-08-17
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-08-17 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 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... on 2012-08-17. FDA classified it as Class II and gives the reason as "Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0388-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-17
Posted: 2012-11-19
Terminated: 2014-04-10
Recalling firm: Howmedica Osteonics Corp
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-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: The firm, Stryker Orthopaedics, notified Domestic locations of this action by e-mail on August 6, 2012 and foreign locations of this action by e-mail on August 7, 2012. Stryker follow-up by sending an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated August 17, 2012 to their consignees/customers via Fed Ex with return receipt. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and return affected product to Attn: Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430 (attach fluorescent orange sticker and mark box with words "Product Recall"), or contact your Stryker Sales Representative to arrange for return of the product ,and complete and return the attached Product Recall Acknowledgment Form within 5 days via fax to 855-251-3635. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100.
Quantity in commerce: Approximately 358 units
Distribution: Worldwide distribution: USA (nationwide) and countries including: Canada, Belgium, Finland, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Portugal, Spain, Turkey and UK.
Product codes and lots: Catalog No: 2030-6535-1 Lot Code: MLDNAV, MLDXV2, MLH11M, MLH17R, MLH3K8, MLH4L6, MLH7RV, MLHK1X, MLHL99, MLJDJT Ref 2030-6535-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0388-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0387-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0388-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19

Product code HWC

K894124Class IIOmnifit Self Tapping Cancellous Bone ScrewsOsteonics Corp. / cleared 1989-09-11

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)