Stryker Howmedica Osteonics Corp.: 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.

Recall number

Z-0804-2012

Recalling firm

Stryker 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.

Status

Terminated

Initiated

2011-08-19

Posted

2012-01-18

Terminated

2017-07-11

Reason

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

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

106 UNITS

Distribution

USA (nationwide distribution)

Lot, serial or model codes

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 "

510(k) numbers

not on file

PMA numbers

not on file

Product code

LXH

Firm FEI

3003070421

Firm city

Mahwah

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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