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

FDA device recall Z-0804-2012 · posted 2012-01-18 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LXH

Quantity affected

106 UNITS

Distribution

USA (nationwide distribution)

Date initiated

2011-08-19

Date posted

2012-01-18

Date terminated

2017-07-11

Location

Mahwah, NJ