Recall Z-0154-2013— DePuy Mitek, Inc., a Johnson & Johnson Co.

Name: FDA recall Z-0154-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-06

Class II · Terminated

Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2012-09-06, terminated 2015-06-03. It names 2 FDA 510(k) clearances: K060271, K041069. Product: SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow. Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision.

Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson Co.
Classification: Class II
Status: Terminated
Initiated: 2012-09-06
Terminated: 2015-06-03
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K060271 — SPIRALOK ANCHORDepuy Mitek, A Johnson & Johnson Company·cleared 2006-05-04
K041069 — SPIRALOK ANCHORDepuy Mitek, A Johnson & Johnson Company·cleared 2004-11-09

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

SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

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