Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Synthes (USA) Products LLC
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Product Codes/Lot Numbers:
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
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2138-2016
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