FDA (Devices) recall action 63121

DePuy Mitek, Inc., a Johnson & Johnson Co. recalled 16 products on 2012-10-31

The FDA (Devices) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.

Products: 16
Announced: 2012-10-31
Critical: 0
Units: 78,594

Why these products were recalled

Fracture of SPIRALOK Anchors post op, requiring patient revision

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–16 of 16

SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls 94 SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 94 SpiraLok 6.5mm anchors because they fractured after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 314 units of SpiraLok 6.5mm anchors because they may fracture after surgery, requiring patients to undergo revision surgery.
Product
SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
SpiraLok 5.0mm Anchors Recalled for Post-Operative Fracture Risk
DePuy Mitek is recalling 232 units of SpiraLok 5.0mm anchors due to post-operative fractures requiring patient revision surgery.
Product
SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling SpiraLok 6.5 anchors because they may fracture after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
SpiraLok 6.5mm Anchors Recalled Due to Post-Operative Fracture
DePuy Mitek is recalling 372 units of SpiraLok 6.5mm anchors because they fractured after surgery, requiring patient revision.
Product
SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 2,560 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision surgery.
Product
SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers all lot codes distributed worldwide.
Product
SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SpiraLok 5.0mm Anchors Due to Fracture Risk
DePuy Mitek is recalling 400 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring revision.
Product
SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls Seven SpiraLok 6.5 Anchors Due to Fracture Risk
DePuy Mitek is recalling seven SpiraLok 6.5 anchors because they fractured after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 4,321 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.
Product
SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SPIRALOK Bone Fixation Anchors Due to Fracture
DePuy Mitek is recalling 66 SPIRALOK bone fixation anchors because they can fracture after surgery, requiring patients to undergo revision surgery.
Product
Screw, fixation, boneProduct Number: 222967 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 1,315 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls Seven SpiraLok 5.0 Anchors Due to Fracture
DePuy Mitek is recalling seven SpiraLok 5.0 anchors because they fractured after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 25,393 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision.
Product
SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 4,151 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.
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
Category
Distribution
0 states
SevereFDA (Devices)··2012-10-31
DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 39,362 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.
Product
SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 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
Category
Distribution
0 states