Recall Z-2099-2013— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-2099-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-08

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2013-07-08, terminated 2015-03-31. It names one FDA 510(k) clearance: K000080. Product: Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.. Reason: Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Terminated: 2015-03-31
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K000080 — ASNIS III CANNULATED SCREW SYSTEMHowmedica Osteonics Corp.·cleared 2000-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

Reason for recall

Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.

Data sourced from openFDA. This site is unofficial and independent of the FDA.