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REFLECTION
Smith & Nephew, Inc. · Model 730071 · UDI-DI 03596010258366
JDG
Prescription
1
510(k) clearances
6,699
Adverse events (11 deaths)
18
Recalls
58
Facilities
Description
REFLECTION TRIAL ACETABULAR SHELL 71MM OD
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-15 | Waldemar Link GmbH & Co. KG (Mfg Site) | Inconsistent size terminology and color coding used on labeling |
| 2025-07-15 | Waldemar Link GmbH & Co. KG (Mfg Site) | Inconsistent size terminology and color coding used on labeling |
| 2024-02-06 | Waldemar Link GmbH & Co. KG (Mfg Site) | Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpreta |
| 2024-02-06 | Waldemar Link GmbH & Co. KG (Mfg Site) | Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpreta |
| 2024-02-06 | Waldemar Link GmbH & Co. KG (Mfg Site) | Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpreta |
| 2024-02-06 | Waldemar Link GmbH & Co. KG (Mfg Site) | Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpreta |
| 2021-12-30 | Howmedica Osteonics Corp. | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. |
| 2021-12-30 | Howmedica Osteonics Corp. | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. |
| 2021-10-15 | Howmedica Osteonics Corp. | XXX |
| 2021-10-15 | Howmedica Osteonics Corp. | There is a potential for the outer white Tyvek lid to debond from the sealed package. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.