Poly Component Trial — Class II medical device recall Z-1514-2017
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2017-03-29, distributed in AR, MA. The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
| Recall number | Z-1514-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2017-02-20 |
| Classified | 2017-03-21 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-10-27 |
| Distributed | AR, MA |
| Quantity | 72 units |
| Reason classes | packaging |
| Model numbers | 90-SRK-170310, 90-SRK-170312, 90-SRK-170314, 90-SRK-170410, 90-SRK-170412, 90-SRK-170414, 90-SRK-170510, 90-SRK-170512, 90-SRK-170514, 90-SRK-170610, 90-SRK-170612, 90-SRK-170614, TU53733-01, TU53733-02, TU53733-03, TU53733-04, TU53736-01, TU53736-02, TU53736-03, TU53736-04, TU53737-01, TU53737-02, TU53737-03, TU53737-04 |
Product
Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 d) Poly Comp Trial - UCCS 4x10, REF 90-SRK-170410 e) Poly Comp Trial - UCCS 4x12, REF 90-SRK-170412 f) Poly Comp Trial - UCCS 4x14, REF 90-SRK-170414 g) Poly Comp Trial - UCCS 5x10, REF 90-SRK-170510 h) Poly Comp Trial - UCCS 5x12, REF 90-SRK-170512 i) Poly Comp Trial - UCCS 5x14, REF 90-SRK-170514 j) Poly Comp Trial - UCCS 6x10, REF 90-SRK-170610 k) Poly Comp Trial - UCCS 6x12, REF 90-SRK-170612 l) Poly Comp Trial - UCCS 6x14, REF 90-SRK-170614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
Reason for recall
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
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-1514-2017. 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.