Z-2138-2016Class II

Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

Name: Z-2138-2016 Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Creator: Synthes (USA) Products LLC
Published: 2016-05-31
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-05-31 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue on 2016-05-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2138-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-31
Posted: 2016-07-07
Terminated: 2017-04-25
Recalling firm: Synthes (USA) Products LLC
Product: Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Synthes mailed to customers (Hospital Personnel and Sales Consultants) an URGENT FIELD SAFETY NOTIFICATION letter informing them the insert they received, which contained incorrect MR Safety Information, does not meet the current ASTM standards. Customers were asked to review the package insert provided with the notification letter, discard the outdated package insert, complete the attached verification Section (page 3 of this notification) and send a copy of the completed Verification Section by Fax: 844-782-5568 or scan/email: [email protected]. For further questions call (610) 719-6500.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2138-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2138-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-07

Product code MBI

K994364Class IISynthes Button PlateSynthes (Usa) / cleared 2000-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)