Synthes Ti Button Plate 7 Holes recall
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Why was Synthes Ti Button Plate 7 Holes recalled?
DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 1749148, 1896349, 3057585, 3126474, 3277587, 3527962, 3666979, 3723149, 3754359, 3754360, 3800237, 3800239, 3825498, 4182364, 4182365, 4184238, 4184239, 4184240, 4184241, 4186156, 4186158, 4186159, 4201866, 4201867, 4201868, 4205288, 4872583, 4894156, 4894157, 4931671, 4931672, 4931673, 4952212, 4992237, 4992836, 5004334, 5083067, 5106349, 5115240, 5115241, 5127039, 5153048, 5153049, 5328496, 5337095, 5339819, 5344347, 5369177, 5391267, 5404749, 5450581, 5485082, 5510560, 5510561, 5510562, 5510563, 5510564, 5510565, 5583188, 7554579, 7554580, 7559611, 7559614, 7571578, 7571579, 7580696, 7583500, 7596250, 7780217, 7784418, 7784419, 7875460, 7923388, 7949747, 7992504, 8024598, 8060315. 8155523, 8203696, 8226175, 8238466, 8292917,8312365,8348012,8377148,8504955,8612171,8688476,8701156,8711152,8743078,8743084 8756426, 8756427, 8834945,8840904,8948836,8948838,9079710,9079712,9079716,9172619,9172621,9237247 9361663, 9361665, 9432606, 9432608, 9494467, 9494469, 9608863, 9647283, 9665152, 9671639, 9715870, 9720837, 9720840, 9783567, 9783570,. 9788216, 9801777, 9810012, 9823178, 9829378, 9836403, 9836404, 9836405, 9896775, 9913152 Part Numbers: 482.823, Device Listing Number: D194880
- Product
- Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 6,255 units
- Distribution
- USA Distribution to the states of : AK,AL,AR,AZ,CA,CH,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,ON,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI, & WV
- Recall date
- July 13, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)