Synthes Ti Button Plate 7 Holes — Class II medical device recall Z-2138-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-07-13, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with
| Recall number | Z-2138-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2016-05-31 |
| Classified | 2016-07-07 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2017-04-25 |
| Distributed | AK, AL, AR, AZ, CA, 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, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Quantity | 6,255 units |
| Reason classes | labeling |
| 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 and 89 more |
| Model numbers | 482.823 |
Product
Synthes Ti Button Plate 7 Holes, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2138-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.