Z-0804-2012

Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical...

Name: Z-0804-2012 Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2011-08-19
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-08-19 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Straight Command... on 2011-08-19. The reason FDA records is "Stryker Orthopaedics has become ware that there is the potential for the above referenced instruments to fracture in two pieces along the width of the body under the striking plate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0804-2012
Status: Terminated
Initiated: 2011-08-19
Posted: 2012-01-18
Terminated: 2017-07-11
Recalling firm: Howmedica Osteonics Corp
Product: Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Straight Command Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Accolade Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Accolade Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Locking Accolade Straight Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Woodpecker Adapted Accolade Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430 The Handles are instruments that attach to the femoral rasps or broaches to prepare the Femoral Canal in total hip replacement procedures. The rasps have a geometry similar to the final size and shape of the implant. The straight design allows the rasp handle to be used in standard or minimally invasive approaches because it minimizes the contact with adjacent soft tissue. The Handle is impacted with a slotted mallet on the top and on the bottom portions of the striking plate, to achieve rasp insertion and extraction respectively. The handles share the same geometry in the region that is of interest in this matter.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Stryker Orthopaedics has become ware that there is the potential for the above referenced instruments to fracture in two pieces along the width of the body under the striking plate.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker Orthopaedics sent a Urgent Product Recall update dated August 18, 2011, via FedEx to all affected customers. The letter identified the product(s) the problem and the action needed to be taken by the customer. Our records indicate that you have received the above referenced product(s). It is Stryker's responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form within 5 days to 201-831-6069. Please also contact the hospitals in your territory that have the affected product to arrange return of the product as replacement product becomes available. If you have any further questions please call (201) 831-5158.
Quantity in commerce: 106 UNITS
Distribution: USA (nationwide distribution)
Product codes and lots: 510 K exempt. All lots I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H1427HFOO "

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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)